Ammonium Lactate Cream 12%*

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date: 2026-08-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 9
Source: daily-update
Hydrated at: 2026-08-20 01:04:34

Label at a glance#

ProductAmmonium Lactate

Active ingredientAMMONIUM LACTATE

Label structure12 sections

Indications and uses

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

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-866-923-4914

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only.

For Dermatological Use only.
Not for Ophthalmic, Oral or Intravaginal Use.

DESCRIPTION

DESCRIPTION SECTION

* 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

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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 & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNING

WARNINGS SECTION

Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONSsection). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

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

INFORMATION FOR PATIENTS SECTION

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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 vivomicronucleus 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

PREGNANCY SECTION

Teratogenic effects

TERATOGENIC EFFECTS SECTION

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

NURSING MOTHERS SECTION

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

PEDIATRIC USE SECTION

The safety and effectiveness of Ammonium Lactate Cream, 12% have been established in pediatric patients as young as 2 years old.

Geriatric Use

GERIATRIC USE SECTION

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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Ammonium Lactate Cream, 12% is available as follows:
1-140 gram laminate tube NDC 51672-1301-2
2-140 gram laminate tubes NDC 51672-1301-4
385 gram plastic bottle NDC 51672-1301-0

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

SPL UNCLASSIFIED SECTION

Mfd. by: Sun Pharma Canada Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512

Revised: October 2025

5266345 34

PRINCIPAL DISPLAY PANEL - 385 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-1301-4

Ammonium Lactate Cream 12%*

carton label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1301-0	GM - Gram	51672-1301	b5fa1882-d4f1-4e01-a2f5-34f3bc293f42	1	2012-07-24
51672-1301-2	GM - Gram	51672-1301	de135ead-9564-4e4f-8a3f-b686bf6adea7	1	2024-10-04
51672-1301-4	GM - Gram	51672-1301	a148ad99-5bd0-4e0f-a744-ca5b34f0de6d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ammonium Lactate	ACTIVE INGREDIENT	67M901L9NQ	3
Lactic acid	ACTIVE MOIETY	33X04XA5AT	3
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	3
laureth-4	INACTIVE INGREDIENT	6HQ855798J	3
light mineral oil	INACTIVE INGREDIENT	N6K5787QVP	3
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	3
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	3
water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Ammonium Lactate
LACTIC ACID, UNSPECIFIED FORM
CETYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
LAURETH-4
LIGHT MINERAL OIL
MAGNESIUM ALUMINUM SILICATE
METHYLPARABEN
PROPYLPARABEN
PEG-100 STEARATE
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-1301	51672-1301-4, 51672-1301-0, 51672-1301-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMMONIUM LACTATE	67M901L9NQ	ACTIM
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
LAURETH-4	6HQ855798J	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2025-07-01	full-release	2026-05-31 21:36:32

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CREAM / TOPICAL		86000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CREAM / TOPICAL		86000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CREAM / TOPICAL		86000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	CREAM / TOPICAL		86000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PEG-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	CREAM / TOPICAL	1.1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075883-001	AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2003-04-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075883-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2003-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2003-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB	RS	2003-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075883-001	AMMONIUM LACTATE	EQ 12% BASE	CREAM / TOPICAL	AB		2003-04-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075883-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075883-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075883-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075883-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075883-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075883-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075883-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075883-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075883-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075883-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075883-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075883-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075883-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075883-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075883-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075883-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075883-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075883-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075883-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075883-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075883-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075883-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075883-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075883-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075883-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075883-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075883-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075883-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075883-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075883-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075883-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075883-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075883-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075883-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075883-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075883-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075883-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075883-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075883-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075883-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ammonium Lactate	AMMONIUM LACTATE	Sun Pharmaceutical Industries, Inc.	9745b6ce-f532-4e80-b6e9-477ab9db4e30	2026-08-17	Warnings, Adverse reactions	Exact identifier ndc (package): 51672-1301-0 ndc (package): 51672-1301-4 ndc (package): 51672-1301-2 ndc (product): 51672-1301 ndc11 (package): 51672130100 ndc11 (package): 51672130102 ndc11 (package): 51672130104 spl id: 593e7b4f-b89a-b746-e063-6394a90aa570 spl set id: 9745b6ce-f532-4e80-b6e9-477ab9db4e30

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.