warnings
Warnings For external use only
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
- FERRIC OXIDE RED
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 66e98554-e158-a519-e053-2a91aa0a6783
- SPL ID
- 1a3dc619-6b13-21b4-e063-6294a90acb1e
- Version
- 5
- Effective date
- 2024-06-06
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:32:32
| 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 | FERRIC OXIDE RED | openfda.generic_name | |
| manufacturer name | NuCare Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 68071-4322-6 | openfda.package_ndc |
| ndc | product | 68071-4322 | openfda.product_ndc |
| ndc11 | package | 68071432206 | derived:openfda.package_ndc |
| rxcui | 617954 | openfda.rxcui | |
| spl id | 1a3dc619-6b13-21b4-e063-6294a90acb1e | id | |
| spl set id | 66e98554-e158-a519-e053-2a91aa0a6783 | 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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse reactions Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 063.000/063AA
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.