Calamine
- Product NDC
- 46122-809
- 11-digit product format
- 461220809
- Labeler code
- 46122
- Product ID
- 46122-809_498db13a-f81f-8a0a-e063-6294a90a814c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- AMERISOURCE BERGEN
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-23
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 80; 80 mg/100mL; mg/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Calamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 80 mg/100mL |
| ZINC OXIDE | 80 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 617954 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 90d9d908-57ea-4062-ade0-8a4888939c91 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46122-809-29 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-809-29 | ML - Milliliter | 46122-809 | e9e2817b-7f70-4097-9317-8cba5b27c622 | 1 | 2025-12-16 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 1ac59efd-9efd-09d9-e063-6394a90a5e40 | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a3424b96-74b0-21c4-e053-2a95a90ae7ea | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | a4eb1cad-a9c0-43d3-e053-2995a90a06a0 | 2025-01-20 | Warnings | M016 |
| RICO Hand Sanitizer Wipes | ALCOHOL | HANUL CO.,LTD | dc8ba3a2-9748-ec52-e053-2995a90a638b | 2025-01-20 | Warnings | M016 |
| Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a4fa65f9-9786-76dd-e053-2995a90a6e13 | 2025-01-20 | Warnings | M016 |
| SAN Skinlab Cloth Wet Wipes | BENZALKONIUM CHLORIDE 0.13% | HANUL CO.,LTD | c058d278-3d6d-7e3c-e053-2995a90a6c2f | 2025-01-20 | Warnings | M016 |
| Rico Hand Sanitizer | ALCOHOL | HANUL CO.,LTD | a6065fcd-3968-d5a1-e053-2a95a90ab8d6 | 2025-01-20 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4465b-6e46-51e2-e063-6294a90a695f | 2025-01-16 | Warnings | M016 |
| VITAMIN A and D | WHITE PETROLATUM | VIVE HEALTH LLC | 2bd4a2b0-f586-3ab1-e063-6294a90aa1ed | 2025-01-16 | Warnings | M016 |
| Dermoia Manuka Honey Eczema | OATMEAL | TREASUREWISE LLC | 18c174de-6626-45ee-a6aa-f75a48daab8d | 2025-01-15 | Warnings | M016 |
| Allantoin | MEDICINAL MASSAGE OIL | Carolina Cannabis Creations L.L.C | 04b5619b-2122-f159-e063-6394a90a2e05 | 2025-01-15 | Warnings | M016 |
| Skin Barista 2in1 White Body Perfection | DIMETHICONE | Pioom Cosmetic Co.,ltd | 2d7fc20c-31a7-195b-e054-00144ff88e88 | 2025-01-15 | Warnings | M016 |
| Skin Barista Rice Bran Cleansing Foam | ALLANTOIN | Pioom Cosmetic Co.,ltd | 2d7fc7f6-1e89-116c-e054-00144ff8d46c | 2025-01-15 | Warnings | M016 |
| Hammertech Vitamin A and D | WHITE PETROLATUM | HAMMER TECH LLC | ffe96aa1-db6b-33e4-e053-6394a90a7e4e | 2025-01-14 | Warnings | M016 |
| NOON Cartessa Accelerate Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 400ead81-ab07-400f-b261-db330e0fd004 | 2025-01-14 | Warnings | M016 |
| NOON Post Procedure Program | ALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE | Noon Aesthetics M.R. Ltd | 9d1d11b4-40ff-4ea8-a3af-655f457c05f1 | 2025-01-14 | Warnings | M016 |
| OLP diaper Rash cream A and D | ZINC OXIDE | OL PHARMA TECH, LLC Drs PHARMACY | d6faa4d9-751c-a1b6-e053-2a95a90aee5b | 2025-01-09 | Warnings | M016 |
| ANTI-ITCH | ZINC ACETATE , DIPHENHYDRAMINE | OL PHARMA TECH, LLC | b79d3096-c609-e710-e053-2995a90a8da2 | 2025-01-09 | Warnings | M016 |
| ANTIBACTERIAL DREAMY FLORALS | GLYCERIN | Quimicas Handal de Centroamerica SA de CV | 09f73bec-516d-90f0-e063-6394a90aecab | 2025-01-08 | Warnings | M016 |
| AOAO Repair Foot Cream | UREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL. | Guangdong Junhui Biotechnology Co.,LTD | 21064e84-c827-ca82-e063-6394a90a6c65 | 2025-01-08 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | 90d9d908-57ea-4062-ade0-8a4888939c91 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | 90d9d908-57ea-4062-ade0-8a4888939c91 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | 90d9d908-57ea-4062-ade0-8a4888939c91 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | 90d9d908-57ea-4062-ade0-8a4888939c91 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 46122-809-29 | 46122080929 | 177 mL in 1 BOTTLE, PLASTIC (46122-809-29) | 177 ml | 2025-04-23 | No | No | Current |