Calamine
- Product NDC
- 72288-436
- 11-digit product format
- 722880436
- Labeler code
- 72288
- Product ID
- 72288-436_4c209f2f-5ca7-8c9c-e063-6294a90a12c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxine HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Amazon.com Services LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-05-21
- 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 |
|---|---|
| aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 72288-436-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 6 |
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 |
|---|---|---|---|---|---|---|
| Vitamin A and D | VITAMIN A AND D | MIDWOOD BRANDS, LLC | 1d0ebe9a-cbc5-1765-e063-6294a90aa476 | 2024-07-18 | Warnings | M016 |
| Kidgets Baby Petroleum Jelly | BABY PETROLEUM JELLY | MIDWOOD BRANDS, LLC. | 1d0eb8be-13b7-c466-e063-6294a90a93b9 | 2024-07-11 | Warnings | M016 |
| Ivarest | ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE | Blistex Inc | 6f68cbbb-6269-4bb3-8cc9-50b146703b42 | 2024-07-09 | Warnings | M016 |
| Best Choice Diaper Rash | ZINC OXIDE | Trifecta Pharmaceuticals USA LLC | 1be37841-e0a8-a0de-e063-6294a90a9eb1 | 2024-06-27 | Warnings | M016 |
| Gas Relief Ultra Strength | SIMETHICONE | Walgreens | 00a9164a-1817-4130-9c7f-9f5833c9690f | 2024-06-26 | Warnings | M016 |
| Astonea Skin Protectant | ZINC OXIDE | ASTONEA LABS PRIVATE LIMITED | e3c7a515-3e77-da85-e053-2995a90a3ee1 | 2024-06-25 | Warnings | M016 |
| Astonea Vitamin A and D | WHITE PETROLATUM | ASTONEA LABS PRIVATE LIMITED | ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf | 2024-06-25 | Warnings | M016 |
| ZOEY NATURALS DIAPER Cream | ZINC OXIDE | Absolutely Natural | 70fac4d6-8833-4799-b6b6-796f8f13f80e | 2024-06-25 | Warnings | M016 |
| Medicated Body | MENTHOL AND ZINC OXIDE | Universal Distribution Center LLC | 2a59a847-cc7a-42cf-b49a-92e7254c1629 | 2024-06-19 | Warnings | M016 |
| THERA Moisturizing Body Shield | DIMETHICONE | McKesson Medical-Surgical Inc. | 56869b64-11ee-4df6-8102-ce5818e0116e | 2024-06-18 | Warnings | M016 |
| Dimethicone | SKIN PROTECTANT | McKesson | 96886b33-44d4-5a2a-e053-2a95a90a505e | 2024-06-18 | Warnings | M016 |
| Derma E Eczema Relief | OATMEAL | derma e | 767c4a76-8ccb-4530-9b4b-a7ea1a596c7f | 2024-06-18 | Warnings | M016 |
| Insect sting relief pad 01 | SODIUM BICARBONATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 1b0f0088-6482-6de7-e063-6294a90aeeb7 | 2024-06-17 | Warnings | M016 |
| THERA Calazinc Body Shield | ZINC OXIDE | McKesson Medical-Surgical Inc. | 974b1046-83ee-4207-91d3-40982beb9c63 | 2024-06-17 | Warnings | M016 |
| Dimethicone | BODY CLEANSER | McKesson | 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8 | 2024-06-14 | Warnings | M016 |
| Dr. Mom Butt Balm | DIMETHICONE PETROLATUM | Ferndale Laboratories, Inc. | ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd | 2024-06-13 | Warnings | M016 |
| Secura Protective | PETROLATUM | Smith & Nephew Medical Ltd | 20906566-fbf2-46d9-a5d8-c7f7356d1080 | 2024-06-12 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | NuCare Pharmaceuticals,Inc. | 66e98554-e158-a519-e053-2a91aa0a6783 | 2024-06-06 | Warnings, Adverse reactions | M016 |
| CVS Health Vitamin A and D Skin Protectant | LANOLIN AND PETROLATUM | CVS Health | fe3ccabb-9644-4091-9dca-ffd96a43ecaf | 2024-05-28 | Warnings | M016 |
| Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash | ZINC OXIDE | Babo Botanicals, Inc. | 186a9642-cd73-adfb-e063-6394a90a75c7 | 2024-05-14 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 6 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 6 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72288-436-30 | 72288043630 | 177 mL in 1 BOTTLE, PLASTIC (72288-436-30) | 177 ml | 2018-05-21 | 0000-00-00 | No | No | Current |