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 2 of 7 · 135 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Swimmers Ear ISOPROPYL ALCOHOL Walgreens Co 3fb65a5c-c47f-ef2b-e063-6394a90af21a 2026-04-01 Warnings Exact identifier application number: M014 DoloEar CARBAMIDE PEROXIDE Pharmadel LLC 352df636-0469-c33e-e063-6294a90a2224 2026-03-26 Warnings Exact identifier application number: M014 Optimel Manuka Dry Eye Drops GLYCERIN Melcare Biomedical Pty Ltd 88c5e2f0-9f7e-62d1-e053-2995a90a9014 2026-03-11 Warnings Exact identifier application number: M014 Optimel Manuka Forte Eye Gel GLYCERIN Melcare Biomedical Pty Ltd 8e0ed6e8-51fc-7c5b-e053-2a95a90a35a9 2026-03-11 Warnings Exact identifier application number: M014 Ear Wash Refill CVS CARBAMIDE PEROXIDE CVS 311c5951-949c-b38b-e063-6294a90aa4a9 2026-02-27 Warnings Exact identifier application number: M014 ProRinse Earwax Removal System CARBAMIDE PEROXIDE McKeon Products Inc ca82db28-1ef7-41c6-a46b-7bfc7b09281c 2026-02-09 Warnings Exact identifier application number: M014 Wax Away Earwax Removal Aid CARBAMIDE PEROXIDE McKeon Products Inc 8e6c8bf3-d3ec-4605-b8e5-47612f94db89 2026-02-09 Warnings Exact identifier application number: M014 Wax Away Earwax Removal System CARBAMIDE PEROXIDE McKeon Products Inc 22c6f7db-814b-4e70-9fbe-bbb86385d070 2026-02-09 Warnings Exact identifier application number: M014 blue goo FREEZING PAIN RELIEF Topical Analgesic MENTHOL 4% Garcoa, Inc. e90e35e8-47a7-4f9b-ba8a-1cfd15b43995 2026-02-06 Warnings Exact identifier application number: M014 CaseysDishwashingSoap DISHWASHING DETERGENT JUNIPER FOREST KYNC DESIGN LLC b563af92-606c-7c12-e053-2a95a90abbb7 2026-01-23 Warnings Exact identifier application number: M014 CaseysLavender CASEYS HAND SOAP LAVENDER SCENT KYNC Design LLC b5bc8770-13ef-36dc-e053-2995a90a3f51 2026-01-23 Warnings Exact identifier application number: M014 Les Coja Organic SPF 30 ETHYLHEXYL SALICYLATE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANE RNA PHARMA, LLC 485d31e4-a2a9-8165-e063-6294a90a14fc 2026-01-14 Warnings Exact identifier application number: M014 Dri-Ear DRI-EAR S.S.S. Company 12f07636-bb60-5fd4-e063-6294a90a39a8 2026-01-08 Warnings Exact identifier application number: M014 Clinere Ear Wax Remover CARBAMIDE PEROXIDE Quest Products d967eac3-0aac-a7ae-e053-2995a90a0e1e 2026-01-08 Warnings Exact identifier application number: M014 Deluxe Ear Wash system CARBAMIDE PEROXIDE Walgreens 14923bf4-5b4f-a26a-e063-6294a90aa6b5 2025-12-10 Warnings Exact identifier application number: M014 Ear Wax Removal Drops CARBAMIDE PEROXIDE - 6.5% GeriCare Pharmaceutical Corp 239702af-cf93-43ee-b1af-8e53642395c1 2025-12-09 Warnings Exact identifier application number: M014 EELHOE Whole Body Deodorant Solid Balm GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 45696491-3c41-39c6-e063-6394a90abae3 2025-12-07 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Peppermint Oil and Aloe Conditioner SALICYLIC ACID RNA PHARMA, LLC 450dff05-9410-5366-e063-6294a90ae0d4 2025-12-03 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Oil Treatment SALICYLIC ACID RNA PHARMA, LLC 450ec8ae-2405-8d2f-e063-6394a90a50db 2025-12-03 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Peppermint Oil and Aloe SALICYLIC ACID RNA PHARMA, LLC 44fa5eed-93e2-cb3a-e063-6294a90a3b04 2025-12-02 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