Ammonium Lactate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Ammonium Lactate
Generic name: AMMONIUM LACTATE
Manufacturer: Bryant Ranch Prepack
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 1d2adae5-0225-4e66-8f4f-14a5ef11e1d0
SPL ID: 00b2a93c-92de-90c6-e063-6294a90a6d33
Version: 105
Effective date: 2023-07-17
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:57

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	075570	derived:openfda.application_number
application number		ANDA075570	openfda.application_number
brand name		Ammonium Lactate	openfda.brand_name
generic name		AMMONIUM LACTATE	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	63629-8610-1	openfda.package_ndc
ndc	product	63629-8610	openfda.product_ndc
ndc11	package	63629861001	derived:openfda.package_ndc
rxcui		197362	openfda.rxcui
spl id		00b2a93c-92de-90c6-e063-6294a90a6d33	id
spl set id		1d2adae5-0225-4e66-8f4f-14a5ef11e1d0	set_id
unii		67M901L9NQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING Sun exposure (natural or artificial sunlight) to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS ). The use of Ammonium Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS 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).

Reported adverse events (FAERS/openFDA)#

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