warnings
Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on children under 2 years of age.
Calamine
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
- Calamine
- Generic name
- CALAMINE AND ZINC OXIDE
- Manufacturer
- Pharma Nobis, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- fbcfa541-beda-06de-e053-6294a90a9298
- SPL ID
- 52b97551-89e2-c3b8-e063-6394a90af476
- Version
- 3
- Effective date
- 2026-05-26
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:11
| 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 number | M016 | openfda.application_number | |
| brand name | Calamine | openfda.brand_name | |
| generic name | CALAMINE AND ZINC OXIDE | openfda.generic_name | |
| manufacturer name | Pharma Nobis, LLC | openfda.manufacturer_name | |
| ndc | package | 82645-418-96 | openfda.package_ndc |
| ndc | product | 82645-418 | openfda.product_ndc |
| ndc11 | package | 82645041896 | derived:openfda.package_ndc |
| rxcui | 617954 | openfda.rxcui | |
| spl id | 52b97551-89e2-c3b8-e063-6394a90af476 | id | |
| spl set id | fbcfa541-beda-06de-e053-6294a90a9298 | set_id | |
| unii | SOI2LOH54Z | openfda.unii | |
| unii | 1K09F3G675 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.