warnings
WARNINGS Keep out of reach of children.
Topicort
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
- Topicort
- Generic name
- DESOXIMETASONE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 96dfac6f-540f-4b7d-bcee-7e62088ebc93
- SPL ID
- 4cd6638c-db25-e28b-e063-6294a90a4a9a
- Version
- 11
- Effective date
- 2026-03-12
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:07
| 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 | NDA | 018594 | derived:openfda.application_number |
| application number | NDA018594 | openfda.application_number | |
| brand name | Topicort | openfda.brand_name | |
| generic name | DESOXIMETASONE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-5263-7 | openfda.package_ndc |
| ndc | package | 51672-5263-3 | openfda.package_ndc |
| ndc | package | 51672-5263-5 | openfda.package_ndc |
| ndc | package | 51672-5263-2 | openfda.package_ndc |
| ndc | package | 51672-5263-1 | openfda.package_ndc |
| ndc | product | 51672-5263 | openfda.product_ndc |
| ndc11 | package | 51672526302 | derived:openfda.package_ndc |
| ndc11 | package | 51672526301 | derived:openfda.package_ndc |
| ndc11 | package | 51672526303 | derived:openfda.package_ndc |
| ndc11 | package | 51672526305 | derived:openfda.package_ndc |
| ndc11 | package | 51672526307 | derived:openfda.package_ndc |
| rxcui | 1050394 | openfda.rxcui | |
| rxcui | 141850 | openfda.rxcui | |
| spl id | 4cd6638c-db25-e28b-e063-6294a90a4a9a | id | |
| spl set id | 96dfac6f-540f-4b7d-bcee-7e62088ebc93 | set_id | |
| unii | 4E07GXB7AU | 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 approximate decreasing order of occurrence: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. In controlled clinical studies the incidence of adverse reactions was low (0.2%) for Topicort ® (desoximetasone ointment USP) 0.05% and included mild burning sensation at the site of application.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.