warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Acetic Acid
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
- Acetic Acid
- Generic name
- ACETIC ACID
- Manufacturer
- TruPharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0c5ebd59-0e98-4ea1-b279-9202a19f6dbf
- SPL ID
- 2a4574f2-001a-ad0a-e063-6394a90a98f6
- Version
- 2
- Effective date
- 2024-12-27
- Source export date
- 2026-11-06
- 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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:02:15
| Harmonized routes |
|---|
| AURICULAR (OTIC) |
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 | 040607 | derived:openfda.application_number |
| application number | ANDA040607 | openfda.application_number | |
| brand name | Acetic Acid | openfda.brand_name | |
| generic name | ACETIC ACID | openfda.generic_name | |
| manufacturer name | TruPharma, LLC | openfda.manufacturer_name | |
| ndc | package | 52817-816-15 | openfda.package_ndc |
| ndc | product | 52817-816 | openfda.product_ndc |
| ndc11 | package | 52817081615 | derived:openfda.package_ndc |
| rxcui | 197305 | openfda.rxcui | |
| spl id | 2a4574f2-001a-ad0a-e063-6394a90a98f6 | id | |
| spl set id | 0c5ebd59-0e98-4ea1-b279-9202a19f6dbf | set_id | |
| unii | Q40Q9N063P | 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 Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.