{"id":"ammonium-lactate","rwe":[],"_fda":{"id":"4f6bc7a2-ebb4-9e33-e063-6294a90a394e","set_id":"030e8bd1-0ff3-479f-aa77-16fab701a111","openfda":{"nui":["N0000175842","M0010745"],"unii":["67M901L9NQ"],"route":["TOPICAL"],"spl_id":["4f6bc7a2-ebb4-9e33-e063-6294a90a394e"],"brand_name":["Ammonium Lactate"],"spl_set_id":["030e8bd1-0ff3-479f-aa77-16fab701a111"],"package_ndc":["70518-3619-0"],"product_ndc":["70518-3619"],"generic_name":["AMMONIUM LACTATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Hydroxy Acids [CS]"],"substance_name":["AMMONIUM LACTATE"],"pharm_class_epc":["alpha-Hydroxy Acid [EPC]"],"manufacturer_name":["REMEDYREPACK INC."],"application_number":["ANDA075883"],"original_packager_product_ndc":["51672-1301"]},"version":"5","warnings":["WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed."],"pregnancy":["Pregnancy Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed."],"description":["DESCRIPTION * Ammonium Lactate Cream, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a cream pH of 4.5 to 5.5. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, propylparaben, polyoxyethylene-100 stearate, polyoxyl 40 stearate, propylene glycol, purified water and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Chemical Structure"],"precautions":["PRECAUTIONS General For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied. Information for Patients Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions: This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with the eyes, lips, or mucous membranes. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose. Pregnancy Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed. Nursing Mothers Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Cream, 12% is administered to a nursing woman. Pediatric Use The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old. Geriatric Use Clinical studies of Ammonium Lactate Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious."],"how_supplied":["HOW SUPPLIED Ammonium Lactate Cream, 12% is available as follows: NDC: 70518-3619-00 PACKAGING: 2 in 1 CARTON, 140 g in 1 TUBE TYPE 0 Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762"],"geriatric_use":["Geriatric Use Clinical studies of Ammonium Lactate Cream, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious."],"pediatric_use":["Pediatric Use The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old."],"effective_time":"20260414","nursing_mothers":["Nursing Mothers Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ammonium Lactate Cream, 12% is administered to a nursing woman."],"adverse_reactions":["ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients."],"contraindications":["CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients."],"general_precautions":["General For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied."],"teratogenic_effects":["Teratogenic effects Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m 2 /day in the rat and 7200 mg/m 2 /day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate cream. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ammonium Lactate Cream, 12% should be used during pregnancy only if clearly needed."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) are felt to act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known. An in vitro study of percutaneous absorption of ammonium lactate cream using human cadaver skin indicates that approximately 6.1% of the material was absorbed after 68 hours."],"indications_and_usage":["INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis."],"information_for_patients":["Information for Patients Patients using Ammonium Lactate Cream, 12% should receive the following information and instructions: This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with the eyes, lips, or mucous membranes. Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin. This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs). If the skin condition worsens with treatment, the medication should be promptly discontinued. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762"],"spl_unclassified_section":["Rx only. For Dermatological Use only. Not for Ophthalmic, Oral or Intravaginal Use.","Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician."],"spl_product_data_elements":["Ammonium Lactate Ammonium Lactate CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE LAURETH-4 LIGHT MINERAL OIL MAGNESIUM ALUMINUM SILICATE METHYLPARABEN PROPYLPARABEN PEG-100 STEARATE POLYOXYL 40 STEARATE PROPYLENE GLYCOL WATER AMMONIUM LACTATE LACTIC ACID, UNSPECIFIED FORM"],"package_label_principal_display_panel":["DRUG: Ammonium Lactate GENERIC: Ammonium Lactate DOSAGE: CREAM ADMINSTRATION: TOPICAL NDC: 70518-3619-0 COLOR: white PACKAGING: 140 g in 1 TUBE OUTER PACKAGING: 2 in 1 CARTON ACTIVE INGREDIENT(S): AMMONIUM LACTATE 120mg in 1g INACTIVE INGREDIENT(S): CETYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE LAURETH-4 LIGHT MINERAL OIL MAGNESIUM ALUMINUM SILICATE METHYLPARABEN PROPYLPARABEN PEG-100 STEARATE POLYOXYL 40 STEARATE PROPYLENE GLYCOL WATER MM1"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility The topical treatment of CD-1 mice with 12%, 21% or 30% ammonium lactate formulations for two years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate cream was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative. In dermal Segment I and III studies with ammonium lactate cream there were no effects observed in fertility or pre- or post-natal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m 2 /day), approximately 0.4 times the human topical dose."]},"tags":[{"label":"alpha-Hydroxy Acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Lotion","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Atopic dermatitis","category":"indication"},{"label":"Contact dermatitis","category":"indication"},{"label":"Dry skin","category":"indication"},{"label":"Eruption of skin","category":"indication"},{"label":"Granuloma annulare","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Sun Pharm Inds Inc","category":"company"},{"label":"Approved 1980s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"138 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"137 reports"},{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"127 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"127 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"120 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"114 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"102 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"101 reports"},{"date":"","signal":"RENAL FAILURE","source":"FDA FAERS","actionTaken":"99 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"95 reports"}],"commonSideEffects":[{"effect":"rash (including erythema and irritation)","drugRate":"10 to 15%","_validated":true,"placeboRate":""},{"effect":"burning/stinging","drugRate":"10 to 15%","_validated":true,"placeboRate":""},{"effect":"itching","drugRate":"5%","_validated":true,"placeboRate":""},{"effect":"transient burning","drugRate":"3%","_validated":true,"placeboRate":""},{"effect":"stinging","drugRate":"2%","_validated":true,"placeboRate":""},{"effect":"dry skin","drugRate":"2%","_validated":true,"placeboRate":""},{"effect":"rash","drugRate":"2%","_validated":true,"placeboRate":""}],"contraindications":["Ammonium Lactate Cream, 12% is contraindicated in patients with a history of hypersensitivity to any of the label ingredients."],"specialPopulations":{"Pregnancy":"There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively (600 mg/kg/day, corresponding to 3600 mg/m2/day in the rat and 7200 mg/m2/day in the rabbit) and have revealed no evidence of impaired fertility or harm to the fetus due to ammonium lactate formulations.","Geriatric use":"Clinical studies of ammonium lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.","Paediatric use":"The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as years old."}},"trials":[],"aliases":[],"company":"Sun Pharma","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0553/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$20","description":"AMMONIUM LACTATE 12% CREAM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMMONIUM LACTATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:24:41.852224+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:24:48.806261+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:24:40.467238+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMMONIUM LACTATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:24:49.521051+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:39.399975+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:39.400040+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:25:14.387080+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:39.400055+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:24:51.824517+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200747/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:24:50.601137+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10 to 15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactat","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:25:03.718454+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:25:06.943137+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA075883","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:24:39.400063+00:00"}},"allNames":"lac-hydrin","offLabel":[],"synonyms":["ammonium lactate"],"timeline":[{"date":"1985-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from RANBAXY to Sun Pharm Inds Inc"},{"date":"1985-04-24","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ranbaxy)"},{"date":"1996-08-29","type":"positive","source":"FDA Orange Book","milestone":"Lac-Hydrin approved — EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2003-04-10","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"}],"aiSummary":"Lac-Hydrin (AMMONIUM LACTATE) is a small molecule alpha-Hydroxy Acid developed by RANBAXY and currently owned by Sun Pharm Inds Inc. It was FDA approved in 1985 for various skin conditions, including atopic dermatitis, contact dermatitis, and dry skin. Lac-Hydrin is available as a generic medication, with multiple manufacturers, and is off-patent. It is used to treat a range of skin issues, including itching and irritation. Key safety considerations include potential skin irritation and allergic reactions.","brandName":"Lac-Hydrin","ecosystem":[{"indication":"Atopic dermatitis","otherDrugs":[{"name":"abrocitinib","slug":"abrocitinib","company":"PFIZER Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"baricitinib","slug":"baricitinib","company":"Eli Lilly And Co"}],"globalPrevalence":204050000},{"indication":"Contact dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"},{"name":"betamethasone","slug":"betamethasone","company":""}],"globalPrevalence":324000000},{"indication":"Dry skin","otherDrugs":[{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"}],"globalPrevalence":null},{"indication":"Eruption of skin","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"},{"name":"betamethasone","slug":"betamethasone","company":""}],"globalPrevalence":null},{"indication":"Granuloma annulare","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"},{"name":"betamethasone","slug":"betamethasone","company":""}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""}],"globalPrevalence":null},{"indication":"Pruritus ani","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"},{"name":"betamethasone","slug":"betamethasone","company":""}],"globalPrevalence":null},{"indication":"Pruritus of genital organs","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"},{"name":"betamethasone","slug":"betamethasone","company":""}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"alpha-Hydroxy Acid [EPC]","explanation":"","oneSentence":"","technicalDetail":"Lac-Hydrin, an alpha-Hydroxy Acid, functions as a keratolytic agent, breaking down keratin in the skin's stratum corneum, thereby promoting exfoliation and hydration."},"commercial":{"launchDate":"1985","_launchSource":"DrugCentral (FDA 1985-04-24, RANBAXY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4476","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMMONIUM%20LACTATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMMONIUM LACTATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:42:08.977158","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T03:25:14.643179+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"ammonium lactate","indications":{"approved":[{"id":"ammonium-lactate-ichthyosis-vulgaris","name":"Ichthyosis vulgaris","dosing":null,"approvals":[],"diseaseId":"","eligibility":null,"pivotalTrial":null,"restrictions":[],"patientPopulation":null,"diagnosticRequired":null,"brandNameForIndication":"Lac-Hydrin"},{"id":"ammonium-lactate-xerosis","name":"Xerosis","dosing":null,"approvals":[],"diseaseId":"","eligibility":null,"pivotalTrial":null,"restrictions":[],"patientPopulation":null,"diagnosticRequired":null,"brandNameForIndication":"Lac-Hydrin"}],"offLabel":[],"pipeline":[]},"currentOwner":"Sun Pharm Inds Inc","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT07492446","phase":"NA","title":"Effects of Carnitine Supplementation on Exercise-Induced Muscle Damage: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"Istanbul Sabahattin Zaim University","startDate":"2025-05-09","conditions":["Recovery Methods","Exercise and Recovery","Exercise Fatigue","Carnitine Ingestion","Exercise 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