warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
calcipotriene
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
- calcipotriene
- Generic name
- CALCIPOTRIENE
- Manufacturer
- Northstar Rx LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a882ef4f-603e-4421-97ae-2c78822c767a
- SPL ID
- ee33f5da-8d1a-429e-aa0c-15d19353fc44
- Version
- 4
- Effective date
- 2024-06-24
- 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 06:24:26
| 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 | 205772 | derived:openfda.application_number |
| application number | ANDA205772 | openfda.application_number | |
| brand name | calcipotriene | openfda.brand_name | |
| generic name | CALCIPOTRIENE | openfda.generic_name | |
| manufacturer name | Northstar Rx LLC | openfda.manufacturer_name | |
| ndc | package | 16714-763-01 | openfda.package_ndc |
| ndc | package | 16714-763-02 | openfda.package_ndc |
| ndc | product | 16714-763 | openfda.product_ndc |
| ndc11 | package | 16714076302 | derived:openfda.package_ndc |
| ndc11 | package | 16714076301 | derived:openfda.package_ndc |
| rxcui | 313921 | openfda.rxcui | |
| spl id | ee33f5da-8d1a-429e-aa0c-15d19353fc44 | id | |
| spl set id | a882ef4f-603e-4421-97ae-2c78822c767a | set_id | |
| unii | 143NQ3779B | openfda.unii |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS Clinical Trials Experience In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis. To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 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.