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 |
|---|---|---|---|---|---|---|
| Softlips Peppermint Swirl | DIMETHICONE | The Mentholatum Company | 4dbea50e-d82d-c702-e063-6394a90ac6e4 | 2026-03-24 | Warnings | M016 |
| Softlips Vanilla | DIMETHICONE | The Mentholatum Company | 56551008-a4e0-406f-8403-980d2e6b75a0 | 2026-03-24 | Warnings | M016 |
| Selan Plus Zinc Oxide | SELAN PLUS ZINC OXIDE | Trividia Manufacturing Solutions, Inc | 07396c61-1dfd-4be7-bddf-0eb570a18463 | 2026-03-24 | Warnings | M016 |
| D-Cerin | MOISTURIZER | Dynarex Corporation | 7ea47a7e-12af-9290-e053-2a91aa0a065f | 2026-03-24 | Warnings | M016 |
| MG217 Eczema Body | COLLOIDAL OATMEAL | Wisconsin Pharmacal Company | 5f0cfd0c-ae87-f411-e053-2a91aa0ac251 | 2026-03-20 | Warnings | M016 |
| Advanced Formula Scar Defense Cream | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d5c70f9-da41-b535-e063-6294a90a73f2 | 2026-03-19 | Warnings | M016 |
| TriplePaste Adult Care Rash Treatment | ZINC OXIDE | Advantice Health, LLC | 2cf0575c-8d3d-1f16-e063-6294a90a629d | 2026-03-19 | Warnings | M016 |
| multipurpose | ZINC OXIDE SKIN PROTECTANT | Advantice Health, LLC | 291563cc-7491-ce41-e063-6394a90ac6c1 | 2026-03-19 | Warnings | M016 |
| Triple Diaper Rash | ZINC OXIDE | Advantice Health, LLC | d457c58d-8239-41c4-999e-d0ba237e3945 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | f4464fb2-ba25-16f2-e053-2a95a90a0406 | 2026-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | fea4e5c7-780c-c7f4-e053-6294a90abb39 | 2026-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d46110b-5aa7-5261-e063-6394a90a423a | 2026-03-18 | Warnings | M016 |
| Advanced Bed Sore Wound Healing | ALLANTOIN | Yantai Aien Biotechnology Co., Ltd. | 4d589c18-e597-355a-e063-6394a90a4243 | 2026-03-18 | Warnings | M016 |
| MediChoice Barrier | DIMETHICONE | O&M HALYARD, INC. | 115c2a2f-d68a-316a-e063-6394a90a2716 | 2026-03-17 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4d4427b0-25c3-ddf6-e063-6394a90a6153 | 2026-03-17 | Warnings | M016 |
| Colloidal Oatmeal | COLLOIDAL OATMEAL | Walmart Inc. | 4a93f77d-41dc-3bab-e063-6394a90a804b | 2026-03-16 | Warnings, Adverse reactions | M016 |
| Vaseline | HEALING JELLY | Conopco Inc. d/b/a Unilever | bd4418b7-c6aa-5e71-e053-2995a90a4cc4 | 2026-03-16 | Warnings | M016 |
| Vaseline Intensive Care Deep Moisture | PETROLEUM | Conopco Inc. d/b/a Unilever | 65cec560-25c7-4076-a33d-a3dd534ff85b | 2026-03-16 | Warnings | M016 |
| Daily Moisturizing | DAILY MOISTRUIZING | Walgreen Co. | 27452cc7-1ec6-4571-bcd0-0a7103735ee5 | 2026-03-13 | Warnings, Adverse reactions | M016 |
| Tender Moments Delicate Baby Diaper Rash Balm | DIMETHICONE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | f09ba452-e1a6-4f45-901f-bb63d4f8e884 | 2026-03-13 | 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 |