warnings and cautions
Rx Only For external use only Not for opthalmic use
Hydrocortisone
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
- Generic name
- HYDROCORTISONE LOTION
- Manufacturer
- Allegis Holdings LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1a27d8fa-4025-ed68-e063-6394a90a4f37
- SPL ID
- 561ef081-6571-b3d1-e063-6394a90a5bc7
- Version
- 3
- Effective date
- 2026-07-08
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:18:02
| 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 | 083231 | derived:openfda.application_number |
| application number | ANDA083231 | openfda.application_number | |
| brand name | Hydrocortisone | openfda.brand_name | |
| generic name | HYDROCORTISONE LOTION | openfda.generic_name | |
| manufacturer name | Allegis Holdings LLC | openfda.manufacturer_name | |
| ndc | package | 71297-010-02 | openfda.package_ndc |
| ndc | package | 71297-010-01 | openfda.package_ndc |
| ndc | product | 71297-010 | openfda.product_ndc |
| ndc11 | package | 71297001002 | derived:openfda.package_ndc |
| ndc11 | package | 71297001001 | derived:openfda.package_ndc |
| rxcui | 197784 | openfda.rxcui | |
| spl id | 561ef081-6571-b3d1-e063-6394a90a5bc7 | id | |
| spl set id | 1a27d8fa-4025-ed68-e063-6394a90a4f37 | set_id | |
| 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 The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an aproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermitis, allergic contact dermatis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Allegis Holdings, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or https://fda.gov/Safety/MedWatch/
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.