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
- CALAMINE, PRAMOXINE HCL
- Manufacturer
- Topco Associates LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 15d1ae3f-509c-4e6b-8f0c-cf9265680358
- SPL ID
- 4ab90806-7257-8b97-e063-6294a90a71c3
- Version
- 7
- Effective date
- 2026-02-13
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:13:17
| 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, PRAMOXINE HCL | openfda.generic_name | |
| manufacturer name | Topco Associates LLC | openfda.manufacturer_name | |
| ndc | package | 76162-336-30 | openfda.package_ndc |
| ndc | product | 76162-336 | openfda.product_ndc |
| ndc11 | package | 76162033630 | derived:openfda.package_ndc |
| rxcui | 1234532 | openfda.rxcui | |
| spl id | 4ab90806-7257-8b97-e063-6294a90a71c3 | id | |
| spl set id | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | set_id | |
| unii | 1K09F3G675 | openfda.unii | |
| unii | 88AYB867L5 | 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 Quality Guaranteed Visit here for more information: http://topbrnds.com/4901jm
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.