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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Vital Line | HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES | ANUBIS COSMETICS SL | ebe024f7-7c45-ad60-e053-2995a90a45d6 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL | ANUBIS COSMETICS SL | ebdddcec-f5da-51fe-e053-2995a90a6167 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE | ANUBIS COSMETICS SL | eb53cba1-0509-43bc-e053-2995a90a5e09 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Spa Line | ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID | ANUBIS COSMETICS SL | eb01a962-ab38-18ec-e053-2995a90acdeb | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | FERULIC ACID, VITAMIN C, DMAE | ANUBIS COSMETICS SL | eaf0770c-795d-0232-e053-2a95a90ae0b5 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Total Hydrating | BETAINE, GLYCERIN, POLYSORBATE 20 | ANUBIS COSMETICS SL | eaefe3b9-9064-18b1-e053-2a95a90a5765 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona Vital Line | HYDROLYZED COLLAGEN | ANUBIS COSMETICS SL | f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 | 2023-08-29 | Warnings | M016 |
| Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | 5378d653-702d-405c-a067-882554aaf93a | 2023-08-21 | Warnings | M016 |
| Quality Choice Anti-itch Medicated | CALAMINE AND PRAMOXINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 5e07f26f-cfb6-57f9-e053-2991aa0a2008 | 2023-08-02 | Warnings | M016 |
| Barrier Balm | BARRIER BALM | Autumn Harp, Inc. | 01df9746-991b-4363-e063-6294a90aaac6 | 2023-08-01 | Warnings | M016 |
| Barrier Cream | ZINC OXIDE | Avasol LLC | bc6a2736-faa6-46d3-af9b-a70f0762e9ce | 2023-05-15 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | bec2f702-5ff5-ea66-e053-2a95a90ad1ec | 2023-01-01 | Warnings | M016 |
| Badger After-BUG Balm | COLLOIDAL OATMEAL | W.S. Badger Company, Inc. | a623da47-cef2-146f-e053-2a95a90afe3a | 2021-11-17 | Warnings | M016 |
| Derma-e Eczema Relief | OATMEAL | Topiderm, Inc | e1797f81-af4b-49e1-9906-dbfd904a282b | 2020-08-19 | Warnings | M016 |
| Resurfix Plus | PETROLATUM | Topiderm, Inc. | f100f43d-6ace-4c3a-9c85-640c0ab2e360 | 2019-11-19 | 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 |