Calamine
- Product NDC
- 76162-336
- 11-digit product format
- 761620336
- Labeler code
- 76162
- Product ID
- 76162-336_4ab90806-7257-8b97-e063-6294a90a71c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-05-21
- 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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1234532 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | 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 |
|---|---|---|---|---|---|---|
| 76162-336-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 7 |
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 |
|---|---|---|---|---|---|---|
| EELHOE Skin Advanced Mole Remove Serum | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3efd75f9-438a-f811-e063-6394a90a9450 | 2025-11-27 | Warnings | M016 |
| EELHOE Wart Remover | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3127d616-1933-e783-e063-6294a90a52f7 | 2025-11-27 | Warnings | M016 |
| EELHOE Tanning Mist | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 32670243-957d-3a95-e063-6394a90a5893 | 2025-11-27 | Warnings | M016 |
| EELHOE Skin Tag Patches | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3ddd3fb0-b824-0cde-e063-6394a90aea6a | 2025-11-27 | Warnings | M016 |
| WART REMOVER | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 3fd47677-52c9-6d43-e063-6294a90aa45b | 2025-11-27 | Warnings | M016 |
| JAYSUING Hair Treatment Green Ginger | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2e8e70de-a2e0-7a71-e063-6294a90a90b8 | 2025-11-27 | Warnings | M016 |
| JAYSUING Liquid Wart Flat | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 3b0c05d1-a00e-97df-e063-6394a90af3d0 | 2025-11-27 | Warnings | M016 |
| JAYSUING 7 Days Nail Fungus Treatment | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 2ef424cc-815a-b331-e063-6394a90aae70 | 2025-11-27 | Warnings | M016 |
| JAYSUING Pain Relief Knee Patches | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 358a3e81-abb5-0a65-e063-6294a90a3d69 | 2025-11-27 | Warnings | M016 |
| Sandra Plasencia PDRN Rejuvenating Serum | RH-OLIGOPEPTIDE-1 | Guangzhou Meijiao Medical Biotechnology Co., Ltd. | 449634c8-ff99-1387-e063-6294a90aef45 | 2025-11-27 | Warnings | M016 |
| GLUTATHIONE | KOJIC ACIDSKIN LIGHTENING | HANCHOYEANBIOTEC Co.,Ltd. | 2be274be-e6d0-d961-e063-6294a90a2190 | 2025-11-27 | Warnings | M016 |
| XIMONTH Bee Venom Joint Cream | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 33d18888-8d06-da13-e063-6294a90a743c | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Wart Remover Patch | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e6965b6-8f08-db62-e063-6394a90a64c9 | 2025-11-26 | Warnings | M016 |
| XIMONTH GLP-1 Patches | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Venom Repair | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 37e40cc1-1121-1eee-e063-6294a90aab26 | 2025-11-26 | Warnings | M016 |
| XIMONTH Liquid Wart Corn Callus Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3a1b872a-2883-0b70-e063-6294a90af9d6 | 2025-11-26 | Warnings | M016 |
| XIMONTH Jimerito Honey For Eyes | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3aa38704-4d2b-ffaf-e063-6294a90a323e | 2025-11-26 | Warnings | M016 |
| XIMONTH Bee Honey Eye Drops | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 3e69c950-bbbc-5c47-e063-6294a90a070e | 2025-11-26 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | 4c7e832e-55f3-4766-98b7-29b17d741a4b | 2025-11-26 | Warnings | M016 |
| Johnsons Baby Care Essentials Gift Set | ZINC OXIDE | Kenvue Brands LLC | 43edc287-57e1-d96e-e063-6294a90ac5a1 | 2025-11-24 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76162-336-30 | 76162033630 | 177 mL in 1 BOTTLE, PLASTIC (76162-336-30) | 177 ml | 2009-05-21 | 0000-00-00 | No | No | Current |