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 6 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SuavEar Earwax Removal Aid EARWAX REMOVAL AID NEILMED PHARMACEUTICALS INC c067f1a4-1f67-3f4d-e053-2a95a90a6095 2024-01-11 Warnings Exact identifier application number: M014 Ear Drops Major CARBAMIDE PEROXIDE 6.5% A-S Medication Solutions eb7df1cc-50db-479a-bc1c-dfd7004dd35b 2024-01-08 Warnings Exact identifier application number: M014 Wax B Gone Ear Wax Removal Drops CARBAMIDE PEROXIDE - 6.5% SIGMAR, LLC 3339cac0-8f32-4f71-bef3-dd1524c4b244 2024-01-08 Warnings Exact identifier application number: M014 Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharma Nobis, LLC e42fd693-24ab-0fc0-e053-2995a90ab954 2023-12-26 Warnings Exact identifier application number: M014 LEADER Ear Drops for Swimmers LEADER EAR DROPS FOR SWIMMERS Cardinal Health, 110 dba Leader 874857eb-2a9d-6ef7-e053-2995a90af156 2023-12-22 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Pharma Nobis, LLC e21e114c-99b6-861c-e053-2995a90aeac1 2023-12-22 Warnings Exact identifier application number: M014 Quality Choice Instant Ear Dry ISOPROPYL ALCOHOL Chain Drug Manufacturing Association 9d3c681b-a941-6ddb-e053-2a95a90ad3bf 2023-12-20 Warnings Exact identifier application number: M014 Premiere Value Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharmacy Value Alliance; LLC 9d606fe6-ae57-724f-e053-2a95a90abffe 2023-12-20 Warnings Exact identifier application number: M014 CVS Ear Drops for Swimmers ISOPROPYL ALCOHOL CVS Pharmacy cc4614ee-5d6e-4a07-9826-aff12cc35abd 2023-12-20 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Randob Labs, Ltd. a9904b63-27a4-205c-e053-2995a90af762 2023-12-19 Warnings Exact identifier application number: M014 DDM Ear Drops for Swimmers ISOPROPYL ALCOHOL Discount Drug Mart 5d565cbc-874b-41dc-e053-2991aa0a6787 2023-12-19 Warnings Exact identifier application number: M014 TopCare Swimmers Ear Drops ISOPROPYL ALCOHOL TOPCO ASSOCIATES 9dccbc25-d954-f917-e053-2a95a90a0eff 2023-12-18 Warnings Exact identifier application number: M014 HEB Water Drying Aid ISOPROPYL ALCOHOL H E B 5d5741f8-64fd-0a9a-e053-2991aa0a0b5e 2023-12-18 Warnings Exact identifier application number: M014 Best Choice Earwax Removal Kit CARBAMIDE PEROXIDE Valu Merchandisers, Co. f943ac0e-8171-446d-8c6c-69612b482643 2023-12-15 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. ba8d71b5-7f1f-44a5-ac5b-1f7ceeb02875 2023-12-15 Warnings Exact identifier application number: M014 DISCOUNT drug mart FOOD FAIR earwax removal kit CARBAMIDE PEROXIDE Discount Drug Mart 83fdf4d6-3cdf-429d-b53d-80775a35d0c9 2023-12-15 Warnings Exact identifier application number: M014 Discount Drug Mart Earwax Removal Drops CARBAMIDE PEROXIDE Discount Drug Mart e30c943e-bba5-4520-8f83-16bfa29ee1cf 2023-12-15 Warnings Exact identifier application number: M014 HUMCO Ear Drops for Swimmers ISOPROPYL ALCOHOL Humco Holding Group, Inc. 6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b2 2023-12-15 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Humco Holding Group, Inc a8c052d8-fb9c-09f2-e053-2a95a90a37af 2023-12-15 Warnings Exact identifier application number: M014 EAR DRYING AGENT ISOPROPYL ALCOHOL 94.998% GLYCERIN 5% Rite Aid 9b4299af-c1a2-43e6-90d4-25f4c89d1bef 2023-12-15 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