Calamine
- Product NDC
- 83324-248
- 11-digit product format
- 833240248
- Labeler code
- 83324
- Product ID
- 83324-248_4bcf3ffc-3e53-c2af-e063-6294a90a6188
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FERRIC OXIDE RED
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Chain Drug Marketing Association
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-26
- Substance
- FERRIC OXIDE RED; ZINC OXIDE
- Active strength
- 80; 80 mg/mL; mg/mL
- 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/mL |
| ZINC OXIDE | 80 mg/mL |
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 |
|---|---|
| 86ff4875-9007-4b7b-8f46-16cbd475d4bb | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-248-06 | 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 |
|---|---|---|---|---|---|
| 83324-248-06 | ML - Milliliter | 83324-248 | 1d8abc00-d25a-45d7-a3cf-3d921ffc987b | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| calahist | CALAMINE AND PRAMOXINE HYDROCHLORIDE | WALGREEN COMPANY | fed45e06-cc53-fbc5-e053-6294a90a1b19 | 2023-10-27 | Warnings | M016 |
| calahist clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | WALGREEN COMPANY | fed469c2-fe13-6726-e053-6394a90a5f51 | 2023-10-27 | Warnings | M016 |
| Dr. Sayman Salve | SALVE | Sheffield Pharmaceuticals LLC | 18bdcd0c-9c81-47e1-ae24-2239ff8fd066 | 2023-10-24 | Warnings | M016 |
| Theriac Advanced Healing | LANOLIN | Sheffield Pharmaceuticals LLC | c780cd27-dc9e-45f3-97f0-e59b1b6b955a | 2023-10-24 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | d66e369e-9b19-b084-e053-2995a90aa259 | 2023-10-23 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Healing | COLLOIDAL OATMEAL | Babo Botanicals, Inc. | 08659a5c-2d10-2f98-e063-6394a90a7760 | 2023-10-23 | Warnings | M016 |
| White Rose Petroleum Jelly | PETROLATUM | J. Strickland & Co. | 1aeb090d-c103-4c2e-accc-d9d248315db9 | 2023-10-21 | Warnings | M016 |
| Tricalm Hydrogel | ALUMINUM ACETATE | MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES | 082c6441-be47-4466-e063-6394a90ad500 | 2023-10-20 | Warnings | M016 |
| Empower | WHITE PETROLATUM, ZINC OXIDE | Bemis Manufacturing Company Inc | 08006b60-966b-155b-e063-6294a90a206a | 2023-10-18 | Warnings | M016 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | M016 |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | M016 |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | M016 |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | M016 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83324-248-06 | 83324024806 | 177 mL in 1 BOTTLE, PLASTIC (83324-248-06) | 177 ml | 2025-02-26 | No | No | Current |