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
- Topco Associates LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 2b32e720-ac71-4d60-bc06-e28a00f8a450
- SPL ID
- 4ab7ad96-87b5-6284-e063-6294a90ae847
- Version
- 22
- Effective date
- 2026-02-13
- Source export date
- 2026-11-06
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:16:26
| 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 number | M016 | openfda.application_number | |
| brand name | Calamine | openfda.brand_name | |
| generic name | FERRIC OXIDE RED | openfda.generic_name | |
| manufacturer name | Topco Associates LLC | openfda.manufacturer_name | |
| ndc | package | 36800-063-34 | openfda.package_ndc |
| ndc | package | 36800-063-30 | openfda.package_ndc |
| ndc | package | 36800-063-26 | openfda.package_ndc |
| ndc | product | 36800-063 | openfda.product_ndc |
| ndc11 | package | 36800006334 | derived:openfda.package_ndc |
| ndc11 | package | 36800006330 | derived:openfda.package_ndc |
| ndc11 | package | 36800006326 | derived:openfda.package_ndc |
| rxcui | 617954 | openfda.rxcui | |
| spl id | 4ab7ad96-87b5-6284-e063-6294a90ae847 | id | |
| spl set id | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 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 REACTION DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0622 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Visit here for more information: http://topbrnds.com/4901jk QUALITY GUARANTEED
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.