HYDROQUINONE 4%
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
- HYDROQUINONE 4%
- Generic name
- HYDROQUINONE
- Manufacturer
- Acella Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 595dfc50-ee6f-41b5-ab5b-4c293aee342b
- SPL ID
- 56437508-18f2-e30c-e063-6394a90a34dc
- Version
- 5
- Effective date
- 2026-07-10
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:27:52
| 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 |
|---|---|---|---|
| brand name | HYDROQUINONE 4% | openfda.brand_name | |
| generic name | HYDROQUINONE | openfda.generic_name | |
| manufacturer name | Acella Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 42192-151-01 | openfda.package_ndc |
| ndc | product | 42192-151 | openfda.product_ndc |
| ndc11 | package | 42192015101 | derived:openfda.package_ndc |
| rxcui | 197795 | openfda.rxcui | |
| spl id | 56437508-18f2-e30c-e063-6394a90a34dc | id | |
| spl set id | 595dfc50-ee6f-41b5-ab5b-4c293aee342b | set_id | |
| unii | XV74C1N1AE | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.