Calamine
- Product NDC
- 11344-136
- 11-digit product format
- 113440136
- Labeler code
- 11344
- Product ID
- 11344-136_5c148e64-6bd1-2028-e063-6294a90a2872
- 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 |
|---|---|---|---|---|---|---|
| Zinc Oxide 20% | ZINC OXIDE | Trifecta Pharmaceuticals USA | 8cbe9b1f-fec0-9579-e053-2995a90ac461 | 2026-06-22 | Warnings | M016 |
| Petroleum Skin Protectant | WHITE PETROLATUM | Walmart Inc. | e294a871-ae73-4a4f-89a3-9ebf0b4fd03a | 2026-06-19 | Warnings, Adverse reactions | M016 |
| Diaper Rash Cream | ZINC OXIDE | Foshan Desha Biotechnology Co., Ltd. | 5487ad62-3d73-042e-e063-6394a90afe8c | 2026-06-18 | Warnings | M016 |
| Baby HealingOintment | PETROLATUM | Foshan Desha Biotechnology Co., Ltd. | 5488b81a-e5fe-1452-e063-6394a90a2ae4 | 2026-06-18 | Warnings | M016 |
| Baby Eczema Moisturizing Cream | COLLOIDAL OATMEAL | Foshan Desha Biotechnology Co., Ltd. | 548a0c34-6aac-14f7-e063-6394a90ae652 | 2026-06-18 | Warnings | M016 |
| Jell with Vitamin A D | LANOLIN, PETROLATUM | Jell Pharmaceuticals Pvt Ltd. | d976e5f0-1be5-d9c4-e053-2a95a90a44a4 | 2026-06-17 | Warnings | M016 |
| Dove | ANTIBACTERIAL CARE BEAUTY BAR | Conopco d/b/a Unilever | 547472cf-4902-584e-e063-6294a90a28ac | 2026-06-17 | Warnings | M016 |
| Dr Sosnowskis Chafing Hero Severe Chafing Balm | LANOLIN | Herstat (USA) Inc. | 389041a8-7316-b38e-e063-6294a90a3e8e | 2026-06-17 | Warnings | M016 |
| Drs. Pharmacy Creamy Cocoa Butter Petroleum Jelly | WHITE PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 546749e3-70c5-10e8-e063-6294a90ad8c4 | 2026-06-16 | Warnings | M016 |
| Drs. Pharmacy Creamy Petroleum Jelly | WHITE PETROLATUM | OL PHARMA TECH, LLC Drs PHARMACY | 54698388-f9e8-c470-e063-6394a90a783b | 2026-06-16 | Warnings | M016 |
| Medline | ZINC OXIDE | Medline Industries, LP | 3c319953-04fc-87a8-e063-6294a90a5058 | 2026-06-15 | Warnings | M016 |
| Calamine, Pramoxind HCl | CALAMINE, PRAMOXIND HCL | H E B | 4a7a0b09-d9bc-e752-e063-6394a90a9f2c | 2026-06-15 | Warnings, Adverse reactions | M016 |
| Calamine, Zinc Oxide | CALAMINE, ZINC OXIDE | H E B | 4a79259e-64ac-d187-e063-6294a90a78db | 2026-06-15 | Warnings, Adverse reactions | M016 |
| HEALMUSZ HEALTHY FEET | UREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEET | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a34b6de-03ec-3be4-e063-6294a90afb52 | 2026-06-14 | Warnings | M016 |
| PUVIDA SNOW BLEACH | NIACINAMIDE 15% SNOW BLEACH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a48ebbd-7c80-1bce-e063-6294a90ab4ae | 2026-06-14 | Warnings | M016 |
| XIMONTH Foot Shoe Deodorizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 541d9ce9-62ad-847e-e063-6394a90a55e0 | 2026-06-13 | Warnings | M016 |
| Skin Protectant with 33% Petrolatum Advance Moisturizing Cream | PETROLATUM | Aldermed Inc. | 87413149-d39f-4f8a-b1c9-6de5eb37ff7e | 2026-06-12 | Warnings | M016 |
| Zinc Oxide 20% | ZINC OXIDE, WHITE PETROLATUM | Aldermed Inc. | 54154a72-27ad-7bfa-e063-6394a90a4eca | 2026-06-12 | Warnings | M016 |
| Circletong Tag Wart Remover Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 541b0fe9-f900-8191-e063-6394a90af321 | 2026-06-12 | Warnings | M016 |
| Baby Butz | ZINC OXIDE | Olen Skin Care Corporation | e6be6b62-13a4-410d-b8ac-457b58fd23da | 2026-06-10 | 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 |