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 |
|---|---|---|---|---|---|---|
| EELHOE Cuticle Pusher Pen | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 52c7f956-a2a1-ae1d-e063-6294a90ab3c2 | 2026-05-27 | Warnings | M016 |
| Dermoia Eczema Relief Colloidal Oatmeal | OATMEAL | Treasurewise LLC | 1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a | 2026-05-27 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Wal-Mart Stores, Inc. | 61e76e2a-fc46-7a64-e053-2991aa0a56a8 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Wal-Mart Stores, Inc. | 61929c97-bd6b-0d7c-e053-2991aa0aa571 | 2026-05-26 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Pharma Nobis, LLC | fbcfa541-beda-06de-e053-6294a90a9298 | 2026-05-26 | Warnings | M016 |
| Humco Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Humco holding Group, Inc. | f7dcd959-fb98-43bb-8dd3-a662bf8a053c | 2026-05-26 | Warnings | M016 |
| Advanced Healing | PETROLATUM | CVS Pharamacy, Inc | 0bd3380e-2284-44a7-b2ef-68c9909627fd | 2026-05-26 | Warnings, Adverse reactions | M016 |
| CeraVe Developed with Dermatologists Healing Lip Balm | PETROLATUM | L'Oreal USA Products Inc | 21dc8842-0672-4d46-bcea-b8e3d54c48bf | 2026-05-20 | Warnings | M016 |
| AFTER CARE | DIMETHICONE | Merz North America | c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae | 2026-05-20 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE | Trifecta Pharmaceuticals USA | 63b551fc-7d16-c099-e053-2a91aa0a5f2c | 2026-05-18 | Warnings | M016 |
| ADVANCED SILICONE SCAR | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 51ffdc45-5acf-ae20-e063-6294a90a55e8 | 2026-05-17 | Warnings | M016 |
| LCFateLC Nail Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 51ea23f4-0a23-4ae1-e063-6394a90aa051 | 2026-05-16 | Warnings | M016 |
| Radlive Active Defense Nano-Silver Cream | COLLOIDAL OATMEAL | SilverCeuticals | 51e23135-008d-9db5-e063-6294a90a7d61 | 2026-05-15 | Warnings | M016 |
| Cerave Developed with Dermatologists Healing | PETROLATUM | LOreal USA Products Inc | de44ac01-ba17-4f97-ac12-9ea348013bde | 2026-05-14 | Warnings | M016 |
| Triple 3x Max Diaper Rash | ZINC OXIDE | Advantice Health, LLC | e554046b-cd0a-4a6e-8f24-2e610c697432 | 2026-05-14 | Warnings | M016 |
| Eczema Therapy | COLLOIDAL OATMEAL | SilverCeuticals | 3a26a35e-a098-0e22-e063-6294a90a96b9 | 2026-05-13 | Warnings | M016 |
| Nail- Pflaster | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 519681bc-6312-f627-e063-6394a90a2845 | 2026-05-11 | Warnings | M016 |
| Hydrating | PETROLATUM | Aldermed Inc. | 4aa6a354-e487-4b65-e063-6394a90abbf0 | 2026-05-09 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Aldermed Inc. | 4aa79292-dc91-b538-e063-6294a90ac3f0 | 2026-05-09 | Warnings | M016 |
| XIMONTH Nail Fungus Care Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 514a998d-aa2a-46b6-e063-6294a90a6c22 | 2026-05-08 | 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 |