Calamine
- Product NDC
- 75981-336
- 11-digit product format
- 759810336
- Labeler code
- 75981
- Product ID
- 75981-336_4b312a63-f96b-3dcb-e063-6394a90a0815
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Pramoxind HCl
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Perrigo Direct, Inc
- 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 |
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 |
|---|---|
| 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 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 |
|---|---|---|---|---|---|---|
| 75981-336-30 | Calamine | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 4 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Honest Eczema Balm | COLLOIDAL OATMEAL | The Honest Company, Inc. | 35b8bc5c-420e-4d31-9659-f36cabbd897a | 2024-05-14 | Warnings | M016 |
| Extra Strength Itch Stopping | ITCH STOPPING CREAM | Universal Distribution Centre LLC | b9a42aa3-1903-76f0-e053-2a95a90a51d1 | 2024-05-13 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Cardinal Health, 110 dba Leader | 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f | 2024-05-13 | Warnings | M016 |
| Walgreens Maximum Diaper Rash | ZINC OXIDE | Walgreens Company | 5eb2152f-6fa2-4191-878a-207416e69818 | 2024-05-07 | Warnings | M016 |
| Cetaphil Eczema Rapid Relief Cream | COLLOIDAL OATMEAL | Galderma Laboratories, L.P. | 02a405fa-8ae9-41e9-b86f-ef5fb6e3844a | 2024-05-02 | Warnings | M016 |
| Chapstick | AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM | Haleon US Holdings LLC | 0e34fc74-772e-48fd-a353-58807ef412c1 | 2024-05-01 | Warnings | M016 |
| Diaper Rash Cream 40% ZINC | ZINC OXIDE | ASTONEA LABS PRIVATE LIMITED | 16da985a-6210-ec82-e063-6294a90a132d | 2024-04-24 | Warnings | M016 |
| Petrolatum Jelly | PETROLATUM | ASTONEA LABS PRIVATE LIMITED | 16dac8e5-aeb8-592d-e063-6394a90ae2b6 | 2024-04-24 | Warnings | M016 |
| Monistat Complete Care Chafing Relief | DIMETHICONE | Insight Pharmaceuticals LLC | 07d7c883-1fa3-4786-905c-a1fab649765e | 2024-04-19 | Warnings | M016 |
| zinc oxide 20% | ZINC OXIDE 20% | Bionpharma Inc | 1549500a-0941-0fba-e063-6394a90a564e | 2024-04-18 | Warnings | M016 |
| ARC Skin Protectant | ALLANTOIN | Anjon Biologics, Inc | f4ff79dd-cb38-4cca-9631-a2758a171873 | 2024-04-18 | Warnings | M016 |
| Zinctral | ZINC OXIDE | PureTek Corporation | de990834-00da-0c7a-e053-2995a90a7c37 | 2024-04-15 | Warnings | M016 |
| Chapstick Moisturizer Variety Pack | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM | Haleon US Holdings LLC | bfb9a2d5-1ad2-45b8-a215-9d1370af5337 | 2024-04-12 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234532 | calamine 8 % / pramoxine HCl 1 % Topical Lotion | PSN | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 4 |
| 1234532 | calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion | SCD | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 4 |
| 1234532 | calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion | SY | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75981-336-30 | 75981033630 | 177 mL in 1 BOTTLE, PLASTIC (75981-336-30) | 177 ml | 2016-09-08 | No | No | Current |