Calamine
- Product NDC
- 11344-063
- 11-digit product format
- 113440063
- Labeler code
- 11344
- Product ID
- 11344-063_5b85784d-fcef-31cf-e063-6294a90a42e7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Zinc oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-07-15
- 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-063-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 3 |
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 |
|---|---|---|---|---|---|---|
| Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fc9eecd-fd25-827c-e063-6394a90a26a5 | 2025-03-26 | Warnings | M016 |
| Cocoa Butter Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fcc9626-6058-e9b3-e063-6394a90ab525 | 2025-03-26 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 313b08e2-d764-96da-e063-6294a90ab705 | 2025-03-25 | Warnings | M016 |
| Eczema Cream | ECZEMA CREAM | Kyte Baby LLC | 30c943aa-d9dc-5c16-e063-6294a90a3c58 | 2025-03-20 | Warnings | M016 |
| Koala Kubs Diaper Rash Cream | DIAPER RASH CREAM | Melaleuca, Inc. | c6b3b0dd-22a8-16f7-e053-2a95a90a51ea | 2025-03-20 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Skin Protectant Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 2b6b8342-878d-4588-8b24-6746d35d319d | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b20bd5-3b4f-8cc7-e063-6394a90a9106 | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b2744d-fb59-f383-e063-6294a90abd2a | 2025-03-19 | Warnings | M016 |
| Dr. Butler Hemorrhoid and Perineal | MINERAL OIL 59.8%,PETROLATUM 36% | Beyond Health P.A. | d17b6f16-6893-ce0a-e053-2a95a90aa23a | 2025-03-19 | Warnings | M016 |
| Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream | DIMETHICONE, WHITE PETROLATUM | Chattem, Inc. | b951d1cb-b81e-4d7f-9a67-8405daa89667 | 2025-03-19 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Hand Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 27457bc5-3edc-4c8b-b8a2-eaf09b511cf8 | 2025-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 30a977c3-6862-670e-e063-6294a90aeb2f | 2025-03-18 | Warnings | M016 |
| YVTYVT Copper Peptides Face Serum | COPPER TRIPEPTIDE-1 | Beijing JUNGE Technology Co., Ltd. | 306f2d48-43b8-359a-e063-6394a90a06dc | 2025-03-16 | Boxed warning, Warnings | M016 |
| Dr Talbots Cooling Perineal Pad | WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE | Talbot's Pharmaceuticals family Products, LLC. | 242277e2-ff26-ad4e-e063-6394a90ab317 | 2025-03-14 | Warnings | M016 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | M016 |
| Aavini Double Layer Brightening Spot Correcting Essence Oil | AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL | Qingyuan Moksha Biotechnology Co., Ltd. | 2ff89a13-3969-2df1-e063-6394a90ac0d3 | 2025-03-10 | Warnings | M016 |
| 5% Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3008bbeb-abba-5cdb-e063-6294a90ae483 | 2025-03-10 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2fc4745c-fac9-7861-e063-6294a90a3f14 | 2025-03-07 | Warnings | M016 |
| AD Skin Protectant | AD SKIN PROTECTANT | WellSpring Pharmaceutical Corporation | d26f1312-2e1b-4106-bc48-a336d4e034ad | 2025-03-07 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Nighttime Balm | OATMEAL | Kenvue Brands LLC | 04d90e45-c2ee-4122-b919-a0eb6d11b59a | 2025-03-04 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | PSN | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion | SCD | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | calamine 8 % / zinc oxide 8 % Topical Lotion | SY | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
| 617954 | Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion | SY | c370ee1f-1887-44e8-8d47-8ffa3c270ff5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-063-30 | 11344006330 | 177 mL in 1 BOTTLE, PLASTIC (11344-063-30) | 177 ml | 1998-07-15 | No | No | Current |