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 |
|---|---|---|---|---|---|---|
| Fresh Scent PROTECTIVE BABY | ZINC OXIDE | CVS Pharmacy, Inc. | 3f33c62c-43ec-4576-a24d-bd5de07e74d2 | 2026-07-23 | Warnings | M016 |
| DERMFREE Vein Target Microneedle Patch | ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57449e29-ec46-9c30-e063-6394a90a7b4a | 2026-07-23 | Warnings | M016 |
| Baby Vitamin A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a125ea-6f9f-310c-e063-6394a90acef2 | 2026-07-22 | Warnings | M016 |
| First Aid A and D | LANOLIN 15.5%, PETROLATUM 53.4% | Walgreen Company | 25a319d0-d39a-5ff0-e063-6394a90a671d | 2026-07-22 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | M016 |
| Dermasporin | LANOLIN | Marie's Original Formulas LLC | 562f40aa-eeec-2b7c-e063-6294a90ad68d | 2026-07-22 | Warnings | M016 |
| CAREALL Vitamin A and D | PETROLATUM | New World Imports, Inc | ef89a68a-74c1-4c42-8078-b7a208ace0de | 2026-07-22 | Warnings | M016 |
| Dermact | LANOLIN | Marie's Original Formulas LLC | 57121dbe-e886-a562-e063-6294a90a367f | 2026-07-22 | Warnings | M016 |
| Universal WITCH HAZEL | WITCH HAZEL | Universal Distribution Center LLC | 7e0b56ef-fa41-4862-b387-5b58d81d67d4 | 2026-07-22 | Warnings | M016 |
| Aveeno Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | 0c410b8e-025f-477c-afac-6e2e9ac88f7d | 2026-07-21 | Warnings | M016 |
| DERMFREE SCAR SHEETS | SILICONE GEL 1% SCAR SHEETS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4ce316-4b92-7e81-e063-6294a90af6db | 2026-07-21 | Warnings | M016 |
| DERMFREE VARICOSE VEINS | DIMETHICONE 3% VARICOSE VEINS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a2d1d-9e84-18eb-e063-6394a90a97ee | 2026-07-21 | Warnings | M016 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 571083ce-cd35-a638-e063-6394a90ae4c7 | 2026-07-20 | Warnings | M016 |
| Mederma Stretch Marks Therapy | DIMETHICONE | PMI Branded Pharmaceuticals, Inc. | 0f2918e3-9615-40e3-ab7e-6bfbe022e03c | 2026-07-16 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | Better Living Brands, LLC | c7ef0ef3-6861-4b94-af4b-371fee8c1f3d | 2026-07-16 | Warnings, Adverse reactions | M016 |
| Dove | MEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BAR | Conopco d/b/a Unilever | 56bd6fcb-c762-4e5a-e063-6394a90a3438 | 2026-07-16 | Warnings | M016 |
| Mederma Advanced Scar | ALLANTOIN | PMI Branded Pharmaceuticals, Inc. | 25bc1eae-3502-4c63-bd8a-43be2dfb0d6d | 2026-07-16 | Warnings | M016 |
| Mederma Advanced Scar | ALLANTOIN | L. Perrigo Company | 9c3d9e08-9428-4b28-82a2-0cb24c3c92a3 | 2026-07-16 | Warnings | M016 |
| aftershave | CERAMIDE NP | Shengnan (Guangzhou) Cosmetics Co., LTD | 56a17ac9-803b-932c-e063-6394a90aae90 | 2026-07-15 | Warnings | M016 |
| Clear Root Labs Wound Care | CRL WOUND CARE OINTMENT | Aidance Scientific Inc. DBA Aidance Skincare & Topicals | 56a6dbc7-5001-c095-e063-6294a90a1aa0 | 2026-07-15 | 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 |