Home NDC 0187-5466 Caladryl Clear
Product NDC 0187-5466
11-digit product format 001875466
Labeler code 0187
Product ID 0187-5466_24adc674-5fba-e779-e063-6294a90ad250
Type HUMAN OTC DRUG
Nonproprietary name PRAMOXINE HYDROCHLORIDE and ZINC ACETATE
Dosage form LOTION
Route TOPICAL
Labeler Bausch Health US, LLC
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-08-16
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength 10; 1 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0187-5466-06 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0187-5466-06 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0187-5466-06 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Clear
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL ZINC ACETATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234546 Internal RxNorm lookup 1234552 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0187-5466-06 Caladryl Clear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5466 CALADRYL CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [BAUSCH HEALTH US, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241019_fca6f08b-7fa0-4ae6-bce3-61f3bcae4332.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 0187-5466-06 00187546606 177 mL in 1 BOTTLE, PLASTIC (0187-5466-06) 177 ml 2013-08-16 0000-00-00 No No Current