Ammonium Lactate Lotion 12%*

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date: 2026-07-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: daily-update
Hydrated at: 2026-08-04 03:36:01

Label at a glance#

ProductAmmonium Lactate

Active ingredientAMMONIUM LACTATE

Label structure13 sections

Indications and uses

Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

Dosage and administration

Shake well. 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 Dermatologic Use Only.
Not for Ophthalmic, Oral or Intravaginal Use.

DESCRIPTION

DESCRIPTION SECTION

*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5. Ammonium Lactate Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

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) may 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 vitrostudy of percutaneous absorption of Ammonium Lactate Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNINGS

WARNINGS SECTION

Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONSsection). The use of Ammonium Lactate Lotion should be discontinued if 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 Lotion, 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 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 formulations enhanced the rate of ultraviolet light-induced skin tumor formation. The mutagenic potential of ammonium lactate formulations 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 formulations 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 formulations. 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 Lotion 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 Lotion is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of Ammonium Lactate Lotion have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use

GERIATRIC USE SECTION

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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 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

OVERDOSAGE

OVERDOSAGE SECTION

The oral administration of Ammonium Lactate Lotion to rats and mice showed this drug to be practically non-toxic (LD ₅₀>15 mL/kg).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle.

STORAGE AND HANDLING SECTION

Store between 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

PRINCIPAL DISPLAY PANEL - 225 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-1300-5

225 g

Ammonium Lactate Lotion 12%*

CONTAINS: *Ammonium lactate equivalent to 12% lactic acid,
cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light
mineral oil, magnesium aluminum silicate, methylcellulose,
methylparaben, polyoxyethylene 100 stearate, polyoxyl
stearate type II, propylene glycol, propylparaben, purified
water, and for pH adjustment: lactic acid.
For Dermatologic Use Only.
Not for Ophthalmic, Oral or Intravaginal Use.
See package insert for full prescribing information.
Store at controlled room temperature 20° to 25°C (68° to 77°F).
For lot number and expiry date see below.

Mfd. by: Sun Pharma Canada Inc.
Brampton, Ontario, Canada L6T 1C1
Dist. by: Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
5265724
Rx only

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51672-1300-5	2023-02-08	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-5	2023-02-08	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-9	2023-02-08	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-9	2023-02-08	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-5	2023-01-30	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-5	2023-01-30	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-9	2023-01-30	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*
51672-1300-9	2023-01-30	C162847	48780-1	f386c649-ee8f-0266-e053-dadaa90a7c1a	Ammonium Lactate Lotion 12%*

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1300-5	GM - Gram	51672-1300	f3e5b834-7369-4e84-9ce1-821a26e0aa25	1	2012-07-24
51672-1300-9	GM - Gram	51672-1300	e7b6d29c-e373-44ab-a3cb-3ad3b3cee0d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ammonium Lactate	ACTIVE INGREDIENT	67M901L9NQ	2
lactic acid	ACTIVE MOIETY	33X04XA5AT	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	2
laureth-4	INACTIVE INGREDIENT	6HQ855798J	2
light mineral oil	INACTIVE INGREDIENT	N6K5787QVP	2
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
peg-100 stearate	INACTIVE INGREDIENT	YD01N1999R	2
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

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
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
POLYOXYL 40 STEARATE
LAURETH-4
CETYL ALCOHOL
LIGHT MINERAL OIL
METHYLPARABEN
PROPYLPARABEN
WATER
MAGNESIUM ALUMINUM SILICATE
PROPYLENE GLYCOL
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-1300	51672-1300-5, 51672-1300-9

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2025-07-01	full-release	2026-05-31 21:36:31

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 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
peg-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
peg-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
magnesium aluminum silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
peg-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
polyoxyl 40 stearate	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
laureth-4	LAURETH-4	6HQ855798J	LOTION / TOPICAL	1.3 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form 3 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
A076216-001	AMMONIUM LACTATE	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB		2004-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076216-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076216-001	AMMONIUM LACTATE	EQ 12% BASE	LOTION / TOPICAL	AB	2004-05-28	`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	A076216-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076216-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076216-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076216-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076216-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076216-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076216-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076216-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076216-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076216-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076216-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076216-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076216-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076216-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076216-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076216-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076216-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076216-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076216-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076216-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076216-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076216-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076216-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076216-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076216-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076216-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076216-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076216-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076216-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076216-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076216-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076216-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076216-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076216-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076216-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076216-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076216-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076216-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076216-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076216-001	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.	8bb09bb3-5bbc-489d-96c1-ae97cb58381e	2026-07-30	Warnings, Adverse reactions	Exact identifier ndc (package): 51672-1300-5 ndc (package): 51672-1300-9 ndc (product): 51672-1300 ndc11 (package): 51672130009 ndc11 (package): 51672130005 spl id: 57d7e3ba-2c3e-a79b-e063-6394a90a4a5b spl set id: 8bb09bb3-5bbc-489d-96c1-ae97cb58381e

Reported adverse events (FAERS/openFDA)#

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