warnings
WARNINGS Use of Adapalene Topical Solution, 0.1% should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.
Adapalene
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
- Adapalene
- Generic name
- ADAPALENE
- Manufacturer
- CALL INC. (dba Rochester Pharmaceuticals)
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 5ce78048-0e5c-45b5-82bf-9f61307611cd
- SPL ID
- 2b371635-a5d6-4596-e063-6394a90a8ee6
- Version
- 7
- Effective date
- 2025-01-08
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:36:56
| 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 | 204593 | derived:openfda.application_number |
| application number | ANDA204593 | openfda.application_number | |
| brand name | Adapalene | openfda.brand_name | |
| generic name | ADAPALENE | openfda.generic_name | |
| manufacturer name | CALL INC. (dba Rochester Pharmaceuticals) | openfda.manufacturer_name | |
| ndc | package | 49908-118-14 | openfda.package_ndc |
| ndc | package | 49908-118-00 | openfda.package_ndc |
| ndc | product | 49908-118 | openfda.product_ndc |
| ndc11 | package | 49908011814 | derived:openfda.package_ndc |
| ndc11 | package | 49908011800 | derived:openfda.package_ndc |
| rxcui | 798061 | openfda.rxcui | |
| spl id | 2b371635-a5d6-4596-e063-6394a90a8ee6 | id | |
| spl set id | 5ce78048-0e5c-45b5-82bf-9f61307611cd | set_id | |
| unii | 1L4806J2QF | 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 Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with the use of adapalene solution during clinical trials were reversible upon discontinuation of therapy. To report SUSPECTED ADVERSE REACTIONS , contact Rochester Pharmaceuticals at 1 -866-458-1772 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.