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 OTIC
- Manufacturer
- Saptalis Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32
- SPL ID
- 339e0417-4d1a-e168-e063-6294a90a50bb
- Version
- 3
- Effective date
- 2025-04-25
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:54:06
| 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 | NDA | 012770 | derived:openfda.application_number |
| application number | NDA012770 | openfda.application_number | |
| brand name | hydrocortisone and acetic acid | openfda.brand_name | |
| generic name | HYDROCORTISONE AND ACETIC ACID OTIC | openfda.generic_name | |
| manufacturer name | Saptalis Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 71656-064-10 | openfda.package_ndc |
| ndc | product | 71656-064 | openfda.product_ndc |
| ndc11 | package | 71656006410 | derived:openfda.package_ndc |
| rxcui | 313786 | openfda.rxcui | |
| spl id | 339e0417-4d1a-e168-e063-6294a90a50bb | id | |
| spl set id | d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32 | 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 Saptalis Pharmaceuticals, LLC at 1-833-727-8254 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.