Caladryl
- Product NDC
- 0187-5465
- 11-digit product format
- 001875465
- Labeler code
- 0187
- Product ID
- 0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bausch Health US, LLC
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-08-16
- Substance
- FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
- Active strength
- 1.36; 10; 78.65 mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Caladryl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FERRIC OXIDE RED | 1.36 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
| ZINC OXIDE | 78.65 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K09F3G675, 88AYB867L5, SOI2LOH54Z |
| Rxcui | 1234532, 1234533 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-5465-06 | Caladryl | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ferric Oxide Red | ACTIVE INGREDIENT | 1K09F3G675 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Pramoxine Hydrochloride | ACTIVE INGREDIENT | 88AYB867L5 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Ferric Oxide Red | ACTIVE MOIETY | 1K09F3G675 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Pramoxine | ACTIVE MOIETY | 068X84E056 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Camphor (Synthetic) | INACTIVE INGREDIENT | 5TJD82A1ET | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Diazolidinyl Urea | INACTIVE INGREDIENT | H5RIZ3MPW4 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-5465 | CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [BAUSCH HEALTH US, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241019_67d4fd42-9fed-4238-9f5a-c9403abbcf20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-5465-06 | 00187546506 | 177 mL in 1 BOTTLE, PLASTIC (0187-5465-06) | 177 ml | 2013-08-16 | 0000-00-00 | No | No | Current |