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 |
|---|---|---|---|---|---|---|
| Cetaphil Soothing Gel Cream | ALLANTOIN | Galderma Laboratories, L.P. | bab404f0-2f7a-4bac-b053-cbdc81c029b5 | 2025-11-24 | Warnings | M016 |
| health beyond VITAMINS AD | PETROLATUM | Nantong Health & Beyond Hygienic Products Inc. | de87da51-cf92-402c-b60f-5f28d1724124 | 2025-11-23 | Warnings | M016 |
| Medline | WHITE PETROLATUM | Medline Industries, LP | 00766a7b-797e-dd15-e063-6394a90af9ac | 2025-11-20 | Warnings | M016 |
| Itch Eraser Sensitive | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 2250525a-45c2-42ea-e063-6394a90ac001 | 2025-11-18 | Warnings | M016 |
| Moisture Barrier Cream | PETROLATUM, ZINC OXIDE | Derma Sciences Canada Inc. | 43e01e22-7872-8e24-e063-6394a90a17ef | 2025-11-18 | Warnings | M016 |
| terrasil Bed Sore and Pressure Sore Relief | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | d0e4a492-f833-4e92-bd4a-b0a07ce9a69e | 2025-11-18 | Warnings | M016 |
| terrasil Foot Ulcer and Sore Relief | ALLANTOIN | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 2776080b-3ddb-ad6c-e063-6394a90a93e0 | 2025-11-18 | Warnings | M016 |
| After Bite Kids | SODIUM BICARBONATE | Tender Corporation d/b/a Adventure Ready Brands | 226c1420-d771-204f-e063-6294a90af9f6 | 2025-11-18 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 280d4bdb-30d3-44f2-9159-3aa9a1de9a5f | 2025-11-17 | Warnings | M016 |
| After Bite X Tech | SODIUM BICARBONATE | Adventure Ready Brands | e9e49ab4-3e1f-9fd4-e053-2a95a90a775a | 2025-11-17 | Warnings | M016 |
| Diaper Rash skin protectant | LANOLIN AND PETROLATUM | Universal Distribution Centre LLC | 29b5475d-6085-cfe6-e063-6294a90a7e74 | 2025-11-17 | Warnings | M016 |
| DERMOGEN | ZINC OXIDE | KRAMER NOVIS | 38e02d1c-c143-4da6-ad32-a3ce2861aac5 | 2025-11-14 | Warnings | M016 |
| Welmedix HomeCare PRO Rapid Relief Rash Cream | PETROLATUM, ZINC OXIDE | Welmedix LLC | 4382a6b4-0b1f-0822-e063-6394a90adffc | 2025-11-14 | Warnings | M016 |
| Petroleum with Cocoa | WHITE PETROLATUM | QUALITY CHOICE (Chain Drug Marketing Association) | 086b6563-cb73-4874-aa42-028f5e81b60d | 2025-11-13 | Warnings | M016 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 43840785-3640-9813-e063-6394a90a7770 | 2025-11-13 | Warnings | M016 |
| Petroleum Jelly Baby Fresh Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309926f-ecd9-635e-e063-6294a90aaab3 | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Fragrance Free 3.53oz | PETROLATUM | Rejoice International Corp. | 12f8d9cc-aa77-e034-e063-6394a90a94dd | 2025-11-11 | Warnings | M016 |
| Petroleum Jelly Cocoa Butter Scent 3.53oz | PETROLATUM | Rejoice International Corp. | 1309b15b-5236-6e9f-e063-6294a90afe11 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Tremella Revitalizing Cleanser | TREMELLA FUCIFORMIS WHOLE | ODLUMIVIE | 435e4736-bcef-c227-e063-6394a90a53d5 | 2025-11-11 | Warnings | M016 |
| ODLUMIVIE Peptide CalmMist | PALMITOYL TRIPEPTIDE-8 | ODLUMIVIE | 435e6717-5fbf-5cb2-e063-6294a90a40d7 | 2025-11-11 | 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 |