Home NDC 0187-5465 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; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 1.36; 78.65; 10 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Caladryl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 1.36 mg/mL ZINC OXIDE 78.65 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup SOI2LOH54Z Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup 1234533 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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.
Matched openFDA labels page 5 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraSeal DIMETHICONE Bausch Health US, LLC 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8 2024-10-17 Warnings Exact identifier application number: M014 fungoid tincture MICONAZOLE NITRATE Pedinol Pharmacal, Inc. 250d0a66-01d1-4aba-8f24-4cb4ca529fda 2024-10-17 Warnings Exact identifier application number: M014 GenRx Anti-Bacterial Gel ALCOHOL PureTek Corporation a124e37e-1a44-212a-e053-2995a90a0af0 2024-10-01 Warnings Exact identifier application number: M014 Hand Sanitizing with Lavender Oil ALCOHOL PureTek Corporation a75d25a7-1e23-717f-e053-2a95a90a6d93 2024-10-01 Warnings Exact identifier application number: M014 Leader Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Cardinal Health, Inc. 0022a174-8377-44af-84a9-31adb27de131 2024-08-23 Warnings Exact identifier application number: M014 Leader Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Cardinal Health 110 DBA Leader 36c1408b-4287-4e9f-aa17-4f05add50038 2024-08-12 Warnings Exact identifier application number: M014 Major Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Major Pharmaceuticals 513bf82e-a36f-49d0-ba74-c834fea4f3b5 2024-08-12 Warnings Exact identifier application number: M014 Alcohol Wipes WIPE EM ALCOHOL WIPES Shaoxing Elite Bio-Tech Co., Ltd. 1f373096-d3d5-af7f-e063-6394a90a3b55 2024-08-08 Warnings Exact identifier application number: M014 Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE NuCare Pharmaceuticals,Inc. b55acec6-5a4d-08b7-e053-2995a90a0f74 2024-07-17 Warnings Exact identifier application number: M014 Bacitracin BACITRACIN NuCare Pharmaceuticals,Inc. a526ae4b-baae-5d50-e053-2a95a90ae293 2024-07-17 Warnings Exact identifier application number: M014 clotrimazole CLOTRIMAZOLE NuCare Pharmaceuticals, Inc. 54241254-1d9a-346a-e054-00144ff8d46c 2024-07-17 Warnings Exact identifier application number: M014 Dr Sheffield Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals,Inc. 5786a559-a387-120d-e053-2991aa0ab647 2024-07-15 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE CVS Pharmacy, Inc. 42a22e06-1b66-4359-852c-7c39e1b3940a 2024-06-24 Warnings Exact identifier application number: M014 Tolnaftate TOLNAFTATE NuCare Pharmaceuticals,Inc. 63665de7-8415-651f-e053-2991aa0ac2bb 2024-06-06 Warnings Exact identifier application number: M014 Rite Aid Earwax Removal Drops CARBAMIDE PEROXIDE Rite Aid 1262531e-0674-cf32-e063-6294a90a0d0b 2024-05-10 Warnings Exact identifier application number: M014 Debrox Kids ISOPROPYL ALCOHOL Medtech Products Inc. f42eee70-c4ee-44ad-85d5-a06d98ecb8b0 2024-05-09 Warnings Exact identifier application number: M014 Rite Aid Swimmers Ear Drops ISOPROPYL ALCOHOL Rite Aid 12875b9d-3ae8-bd0c-e063-6294a90ab4ae 2024-02-29 Warnings Exact identifier application number: M014 Topcare Swimmers Ear Drops ISOPROPYL ALCOHOL Topco Associates LLC 0fddeb43-fee0-d43c-e063-6394a90a738a 2024-01-26 Warnings Exact identifier application number: M014 NeilMed Clear Canal Earwax Removal kit CARBAMIDE PEROXIDE NEILMED PHARMACEUTICALS INC d330552d-07b6-f01e-e053-2a95a90a7ca5 2024-01-11 Warnings Exact identifier application number: M014 Wax Out Plus CARBAMIDE PEROXIDE DROPS NEILMED PHARMACEUTICALS INC cf64f4b8-279c-8c1d-e053-2995a90ac853 2024-01-11 Warnings Exact identifier application number: M014
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