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
- Cosette Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- cef3713f-11f3-4723-9267-3d79855b49bf
- SPL ID
- 106bf241-c85e-8985-e063-6394a90abffb
- Version
- 1
- Effective date
- 2024-02-02
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:03:38
| 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 | 040609 | derived:openfda.application_number |
| application number | ANDA040609 | openfda.application_number | |
| brand name | hydrocortisone and acetic acid | openfda.brand_name | |
| generic name | HYDROCORTISONE AND ACETIC ACID | openfda.generic_name | |
| manufacturer name | Cosette Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 0713-0849-09 | openfda.package_ndc |
| ndc | product | 0713-0849 | openfda.product_ndc |
| ndc11 | package | 00713084909 | derived:openfda.package_ndc |
| rxcui | 313786 | openfda.rxcui | |
| spl id | 106bf241-c85e-8985-e063-6394a90abffb | id | |
| spl set id | cef3713f-11f3-4723-9267-3d79855b49bf | 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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.