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 |
|---|---|---|---|---|---|---|
| Daily Moisturizing | DIMETHICONE | Aldi, Inc | 118a1a07-7283-4353-97b5-6ac3b1cc1430 | 2026-05-08 | Warnings, Adverse reactions | M016 |
| Dove | ANTIBACTERIAL CARE MOISTURIZING CREAM | Conopco Inc. d/b/a/ Unilever | 5150f48c-ff0c-ce39-e063-6394a90ad424 | 2026-05-08 | Warnings | M016 |
| Seedlings Diaper Rash Cream | ZINC OXIDE | Young Living Essential Oils, LC. | 4d8aeaba-ddb1-6f74-e054-00144ff88e88 | 2026-05-08 | Warnings | M016 |
| Nail Repairs Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5120b708-047a-1182-e063-6394a90a74c3 | 2026-05-06 | Warnings | M016 |
| AOAO Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 512185a5-5c1d-ef9f-e063-6394a90a81af | 2026-05-06 | Warnings | M016 |
| AKOLKOL TOENAIL FUNGUS TREATMENT | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5121c341-e5e9-2b36-e063-6394a90a93b8 | 2026-05-06 | Warnings | M016 |
| Beyond Good Diaper Rash | ZINC OXIDE | Babylist, Inc | 512b62df-4f08-d839-e063-6294a90ab52f | 2026-05-06 | Warnings | M016 |
| Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 4c531280-bc5b-1cf2-e063-6394a90a034a | 2026-05-05 | Warnings | M016 |
| PEGO Acne Buster Salicylic Acid Drying Serum | ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID. | Guangzhou Senmai Biotechnology Co.,Ltd. | 511eaced-c4d8-ae94-e063-6394a90a320e | 2026-05-05 | Warnings | M016 |
| Rugby Gas relief | SIMETHICONE | Rugby Laboratories | 9b84f74f-8609-489d-b411-3103afa1b5c2 | 2026-05-04 | Warnings | M016 |
| Vitamin A and D | PETROLATUM | Aldermed Inc. | 3f13a15c-8b64-48f0-a459-853b9097bc31 | 2026-05-04 | Warnings | M016 |
| Zinc Oxide Skin Protectant | ZINC OXIDE 20% | Aldermed Inc. | a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52 | 2026-05-04 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Aldermed Inc. | 4e02af41-db86-46d8-a97d-332d84eced6f | 2026-05-04 | Warnings | M016 |
| Daily Moisturizer | LOTION | Walgreens | fc65f673-b23d-1ffa-e053-6394a90a0966 | 2026-05-03 | Warnings | M016 |
| Dry Skin Healing | PETROLATUM | Walgreen | 0397507d-4b6e-c679-e063-6294a90a0b33 | 2026-05-03 | Warnings | M016 |
| Daily Moisturizer | LOTION | Walgreen | fc67037a-ed31-f678-e053-6394a90a7175 | 2026-05-03 | Warnings | M016 |
| Skin Relief | LOTION | Walgreen | fc678e80-e63d-e3fe-e053-6394a90aa7d6 | 2026-05-03 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Walmart INC | f76ceecc-ef11-3839-e053-6394a90a8d4a | 2026-05-03 | Warnings | M016 |
| Herpecin L | DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE | Focus Consumer Healthcare, LLC | 5b6ed4e9-3e69-c773-e053-2991aa0a7dfe | 2026-05-01 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | Retail Business Services, LLC | 7291e175-a9b6-4c47-93ce-227ce11e4599 | 2026-04-30 | Warnings, Adverse reactions | 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 |