Calamine
- Product NDC
- 11344-136
- Requested package NDC
- 11344-136-30
- 11-digit product format
- 113440136
- Labeler code
- 11344
- Product ID
- 11344-136_4cea1ab2-ca07-7f82-e063-6394a90abe60
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxind HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Nice-Pak Products, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-09-08
- Substance
- FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
- Active strength
- 80; 10 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 |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11344-136-30 | 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 |
|---|---|---|---|---|---|---|
| Dermaka Infants and Kids Multi Purpose Skin Protectant | ZINC OXIDE | Dermaka Skin Products LLC | f84dfd55-db6c-4d75-be67-4d13a139e209 | 2026-09-10 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose | DIMETHICONE | L'Oreal USA Products Inc | 805cd262-2689-4818-8fed-ddefacbdde23 | 2026-09-10 | Warnings | M016 |
| La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose | DIMETHICONE | Cosmetique Active Production | d19f482c-bec7-45aa-b22f-fe91a3dc717d | 2026-09-10 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | CVS Pharmacy, Inc. | 35e67726-4527-4cd7-8e73-30325a32402c | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Lanolin, Petrolatum | LANOLIN, PETROLATUM | CVS Pharmacy, Inc. | 606f65a8-08fd-4ab6-9d68-03ddf662bdf0 | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Eczema Soothing Moisturizing Cream | COLLOIDAL OATMEAL | Nice-Pak Products, LLC | 23548524-2e2e-4d1a-9ebb-6f86d6279e93 | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Advanced Healing | PETROLATUM | Walgreen Co. | 22bd8e87-965c-466b-bb9b-7d4753e500bc | 2026-09-09 | Warnings, Adverse reactions | M016 |
| Drs. pharmacy Scar Cream | ALLANTOIN | OL PHARMA TECH, LLC Drs PHARMACY | d0381034-8cf7-5e8d-e053-2995a90a9faa | 2026-09-09 | Warnings | M016 |
| Drs. Pharmacy baby healing | PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 5b14ffa0-9486-a7fe-e063-6394a90ab3ed | 2026-09-09 | Warnings | M016 |
| Wart Remover | GLYCERIN | Shantou Ouhoe Technology Co., Ltd. | 5af3afe1-dad5-91b7-e063-6294a90ab95e | 2026-09-08 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 5afb3595-f014-153e-e063-6294a90ad34b | 2026-09-08 | Warnings | M016 |
| Medline | DIMETHICONE | Medline Industries, LP | 5afb59b4-491c-45bb-e063-6294a90a0ae6 | 2026-09-08 | Warnings | M016 |
| Claravie | ALUMINUM HYDROXIDE GEL | Gentell LLC | 5afea757-8feb-f907-e063-6394a90a6259 | 2026-09-08 | Warnings | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | United Natural Foods, Inc. dba UNFI | 242adc68-f9e0-4f69-a580-a107d1634b50 | 2026-09-04 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | United Natural Foods, Inc. dba UNFI | 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea | 2026-09-04 | Warnings, Adverse reactions | M016 |
| FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 5a9aaca8-474a-0393-e063-6394a90a5a3a | 2026-09-04 | Warnings | M016 |
| Aveeno Eczema Therapy Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 5a7b0470-3ed5-5b92-e063-6294a90ae0f4 | 2026-09-03 | Warnings | M016 |
| First Aid Beauty Face and Body Bestsellers Kit | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 5a974dbf-84ac-5374-e063-6294a90a8da0 | 2026-09-03 | Warnings | M016 |
| Pure Petrolatum Jelly | PETROLATUM | Jell Pharmaceuticals Pvt. Ltd. | cdc297cb-476a-6da9-e053-2a95a90a399a | 2026-09-02 | Warnings | M016 |
| Nail Treatment Liquid | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 5a7cd607-a50e-17d0-e063-6294a90acdb2 | 2026-09-02 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 9089e23e-ca4a-454f-8dcc-ff5a29a5a335 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11344-136-30 | 11344013630 | 177 mL in 1 BOTTLE, PLASTIC (11344-136-30) | 177 ml | 2016-09-08 | No | No | Current |