warnings
Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on chilren 6 months of age.
Assured 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
- Assured Calamine
- Generic name
- CALAMINE 8% AND ZINC OXIDE 8%
- Manufacturer
- Greenbriar International
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 9d378cc5-9af0-1389-e053-2995a90a0b96
- SPL ID
- 0ccb40f9-0734-b059-e063-6394a90aa03c
- Version
- 3
- Effective date
- 2023-12-18
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:24:08
| 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 | Assured Calamine | openfda.brand_name | |
| generic name | CALAMINE 8% AND ZINC OXIDE 8% | openfda.generic_name | |
| manufacturer name | Greenbriar International | openfda.manufacturer_name | |
| ndc | package | 33992-4130-6 | openfda.package_ndc |
| ndc | product | 33992-4130 | openfda.product_ndc |
| ndc11 | package | 33992413006 | derived:openfda.package_ndc |
| rxcui | 617954 | openfda.rxcui | |
| spl id | 0ccb40f9-0734-b059-e063-6394a90aa03c | id | |
| spl set id | 9d378cc5-9af0-1389-e053-2995a90a0b96 | set_id | |
| unii | SOI2LOH54Z | 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.