warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Hydrocortisone and 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
- Hydrocortisone and Acetic Acid
- Generic name
- HYDROCORTISONE AND ACETIC ACID
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 6383c722-84e2-4719-a13d-19c54e3eefff
- SPL ID
- 395a20ab-856b-3f08-e063-6294a90aa48e
- Version
- 6
- Effective date
- 2025-07-07
- 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 05:15:21
| 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 | 088759 | derived:openfda.application_number |
| application number | ANDA088759 | openfda.application_number | |
| brand name | Hydrocortisone and Acetic Acid | openfda.brand_name | |
| generic name | HYDROCORTISONE AND ACETIC ACID | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-3007-1 | openfda.package_ndc |
| ndc | product | 51672-3007 | openfda.product_ndc |
| ndc11 | package | 51672300701 | derived:openfda.package_ndc |
| spl id | 395a20ab-856b-3f08-e063-6294a90aa48e | id | |
| spl set id | 6383c722-84e2-4719-a13d-19c54e3eefff | set_id | |
| unii | Q40Q9N063P | openfda.unii | |
| unii | WI4X0X7BPJ | 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.