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 |
|---|---|---|---|---|---|---|
| Hydro Gel | GLYCERIN 20% | Trifecta Pharmaceuticals USA LLC | 02e8e5d0-7844-39fe-e063-6394a90a57e1 | 2024-01-19 | Warnings | M016 |
| White Petrolatum | WHITE PETROLATUM | Sled Distribution, LLC | e73a4b7a-7b27-abfc-e053-2995a90a35c2 | 2024-01-15 | Warnings | M016 |
| Sunmark Caldiphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services | 4f4d4c54-64b5-4e20-bed0-c7fb470b8434 | 2024-01-12 | Warnings | M016 |
| EIGHT HOUR NIGHT | DIMETHICONE | REVLON | b3b277f9-565a-636c-e053-2995a90a94d2 | 2024-01-12 | Warnings | M016 |
| CeraVe Developed with Dermatologists Eczema Relief Creamy | OATMEAL | L'Oreal USA Products Inc | bcf7b985-6875-4033-a412-1bb6d3afa6d8 | 2024-01-01 | Warnings | M016 |
| CeraVe Developed with Dermatologists Healing | PETROLATUM | L'Oreal USA Products Inc. | 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95 | 2023-12-31 | Warnings | M016 |
| CeraVe Developed with Dermatologists Baby Healing | PETROLATUM | L'Oreal USA Products Inc. | fe665bbc-1172-4f59-acc6-8d5c179693b6 | 2023-12-31 | Warnings | M016 |
| Quality Choice Anti-Itch Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Market Association | e3c0c46d-3d85-411d-a543-009064cdd19e | 2023-12-28 | Warnings | M016 |
| CeraVe Developed with Dermatologists Therapeutic Hand | DIMETHICONE | L'Oreal USA Products Inc | 7fe49112-4180-415c-a380-768a8d6b2185 | 2023-12-28 | Warnings | M016 |
| Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Pharma Nobis, LLC | e42fccc2-1b4e-e7f3-e053-2a95a90aef39 | 2023-12-26 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Pharma Nobis, LLC | e42fbdcc-3291-7761-e053-2995a90a7172 | 2023-12-26 | Warnings | M016 |
| Humco Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Pharma Nobis, LLC | e42fb807-8cb4-ed25-e053-2995a90a6780 | 2023-12-26 | Warnings | M016 |
| Leader Calamine Plus | ZINC OXIDE LOTION | Cardinal Health, 110 dba Leader | 81f29789-f794-1e64-e053-2a91aa0ac85e | 2023-12-22 | Warnings | M016 |
| CVS Calamine Plus | ZINC OXIDE | CVS Pharmacy | b90cd214-d44a-4458-876d-59cc0795226d | 2023-12-22 | Warnings | M016 |
| Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Pharma Nobis, LLC | e42f0bd6-3ad3-7e07-e053-2995a90a564a | 2023-12-22 | Warnings | M016 |
| DDM Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Discount Drug Mart | 5d53685b-ca4c-35c1-e053-2a91aa0aff6e | 2023-12-20 | Warnings | M016 |
| DDM Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d537a11-049e-0a8d-e053-2a91aa0aa0c3 | 2023-12-20 | Warnings | M016 |
| Health Mart Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | 349ea07d-79bc-46f3-9d60-85b40db51bbb | 2023-12-20 | Warnings | M016 |
| Health Mart Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 2a1d9b27-0bd4-4475-8218-ba0f5560a969 | 2023-12-20 | Warnings | M016 |
| Quality Choice Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Chain Drug Market Association | 62fe653f-e861-472b-b193-4fdd9d25de8d | 2023-12-20 | 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 |