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.
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
- Brand name
- Ammonium Lactate
- Generic name
- AMMONIUM LACTATE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 9745b6ce-f532-4e80-b6e9-477ab9db4e30
- SPL ID
- 593e7b4f-b89a-b746-e063-6394a90aa570
- Version
- 9
- Effective date
- 2026-08-17
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:30
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 075883 | derived:openfda.application_number |
| application number | ANDA075883 | openfda.application_number | |
| brand name | Ammonium Lactate | openfda.brand_name | |
| generic name | AMMONIUM LACTATE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1301-0 | openfda.package_ndc |
| ndc | package | 51672-1301-4 | openfda.package_ndc |
| ndc | package | 51672-1301-2 | openfda.package_ndc |
| ndc | product | 51672-1301 | openfda.product_ndc |
| ndc11 | package | 51672130100 | derived:openfda.package_ndc |
| ndc11 | package | 51672130102 | derived:openfda.package_ndc |
| ndc11 | package | 51672130104 | derived:openfda.package_ndc |
| rxcui | 543460 | openfda.rxcui | |
| spl id | 593e7b4f-b89a-b746-e063-6394a90aa570 | id | |
| spl set id | 9745b6ce-f532-4e80-b6e9-477ab9db4e30 | set_id | |
| unii | 67M901L9NQ | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.