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Ammonium Lactate

Prescription ANDA TE AB Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ammonium Lactate
Generic name
Ammonium Lactate
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Bryant Ranch Prepack
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
9
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ammonium Lactate 12 g/100g 543460 View
Ammonium Lactate 120 mg/g 543460 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
15

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Acidifying Activity [MoA] MoA All 14 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
075774
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 1, 2002
Sponsor
PADAGIS ISRAEL
Products on application
1
Submissions recorded
4
Products approved under application 075774.
Product Trade name Form Strength Ingredient Status TE Flags
075774-001 AMMONIUM LACTATE CREAM AMMONIUM LACTATE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 075774.
Type No. Action Status Date Review
Supplement 4 Labeling Approved June 9, 2009 —
Supplement 2 Labeling Approved December 26, 2002 —
Supplement 1 Manufacturing (CMC) Approved December 26, 2002 —
Original application 1 Approved May 1, 2002 —

Review documents

  • 0 · Original application · July 22, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260817). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260817 HUMAN PRESCRIPTION DRUG · 20260414 HUMAN PRESCRIPTION DRUG · 20230816

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Warnings

openFDA Drug Labeling

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.

Adverse Reactions

openFDA Drug Labeling

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. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Description

openFDA Drug Labeling

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

How Supplied / Storage and Handling

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS
2,119
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: AMMONIUM LACTATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
63629-8608-1 63629-8608 Bryant Ranch Prepack 2 TUBE in 1 CARTON (63629-8608-1) / 140 g in 1 TUBE July 9, 2021
63629-8609-1 63629-8609 Bryant Ranch Prepack 385 g in 1 BOTTLE, PUMP (63629-8609-1) February 19, 2007
72162-1413-2 72162-1413 Bryant Ranch Prepack 2 TUBE in 1 CARTON (72162-1413-2) / 140 g in 1 TUBE August 16, 2023
45802-493-26 45802-493 Padagis Israel Pharmaceuticals Ltd 385 g in 1 BOTTLE, PUMP (45802-493-26) February 19, 2007
45802-493-38 45802-493 Padagis Israel Pharmaceuticals Ltd 385 g in 1 BOTTLE (45802-493-38) March 16, 2026
70518-3619-0 70518-3619 REMEDYREPACK INC. 2 TUBE in 1 CARTON (70518-3619-0) / 140 g in 1 TUBE January 20, 2023
51672-1301-0 51672-1301 Sun Pharmaceutical Industries, Inc. 385 g in 1 BOTTLE, PLASTIC (51672-1301-0) April 10, 2003
51672-1301-2 51672-1301 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE July 1, 2024
51672-1301-4 51672-1301 Sun Pharmaceutical Industries, Inc. 2 TUBE in 1 CARTON (51672-1301-4) / 140 g in 1 TUBE April 10, 2003
63629-8608 63629-8608 Bryant Ranch Prepack — August 16, 2006
63629-8609 63629-8609 Bryant Ranch Prepack — August 16, 2006
72162-1413 72162-1413 Bryant Ranch Prepack — August 16, 2006
45802-493 45802-493 Padagis Israel Pharmaceuticals Ltd — August 16, 2006
70518-3619 70518-3619 REMEDYREPACK INC. — January 20, 2023
51672-1301 51672-1301 Sun Pharmaceutical Industries, Inc. — April 10, 2003

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.