Home NDC 0187-1660 TheraSeal
Product NDC 0187-1660
11-digit product format 001871660
Labeler code 0187
Product ID 0187-1660_24ade6cc-c3b3-2d87-e063-6394a90afc61
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US, LLC
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-01
Substance DIMETHICONE
Active strength 1.7 g/170.1g
Pharmacologic classes Skin Barrier Activity [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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 0187-1660 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0187-1660 0187-1660-06 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 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 TheraSeal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1.7 g/170.1g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200010 Internal RxNorm lookup 826807 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0187-1660-06 TheraSeal 170.1 g in 1 TUBE CREAM 170.1 4 0187-1660-06 TheraSeal 1 in 1 CARTON CREAM 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-1660 THERASEAL (DIMETHICONE) CREAM [BAUSCH HEALTH US, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241019_2c8dc616-20c1-4d33-8a89-9bcdb22b35c8.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 1 of 7 · 135 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ClearCanal Ear Wax Softerner Drops CARBAMIDE PEROXIDE NeilMed Pharmaceuticals, Inc. 0ef2be5b-cc39-48ae-b5c5-e787464dea08 2026-08-17 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 54dc3642-0b7a-07d8-e063-6294a90ad556 2026-07-22 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 55057e1b-b11e-51b9-e063-6394a90a9fca 2026-07-22 Warnings Exact identifier application number: M014 Freskaro Ear Drops for Swimmers FRESKARO EAR DROPS FOR SWIMMERS Pharma Nobis, LLC 4f724d85-cd38-41da-e063-6394a90a9fd7 2026-07-08 Warnings Exact identifier application number: M014 Macks Dry n Clear EAR DRYING AID McKeon Products Inc 1ea1da54-2412-c25c-e063-6294a90aa264 2026-06-26 Warnings Exact identifier application number: M014 Equate Swimmers Instant Ear Dry EQUATE SWIMMERS INSTANT EAR DRY Walmart Stores, Inc 76b58a7a-48cf-866c-e053-2a91aa0a7e63 2026-06-26 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. c68b40d9-c1d4-4425-8063-50c00299e718 2026-06-10 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. b2a641da-e070-4223-b836-5ca9ffb89f3f 2026-06-10 Warnings Exact identifier application number: M014 Audiologists Choice Earwax Removal System CARBAMIDE PEROXIDE Oaktree Products Inc. c9ad507b-341c-474f-aaa2-3c3a97a30dd8 2026-05-29 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Kit CARBAMIDE PEROXIDE CVS Pharmacy, Inc. f842534c-46dd-42c7-8386-9a03ce16da86 2026-05-29 Warnings Exact identifier application number: M014 Lucid Hearing Earwax Removal Kit and Bulb CARBAMIDE PEROXIDE Hearing Lab Technology LLC 5e09f566-397f-44d6-8ba2-90987765c737 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Amerisource Bergen 89eac1b0-c700-45b5-8478-da53ace72e16 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal CARBAMIDE PEROXIDE Amerisource Bergen d503b10f-85cd-4bb8-9dec-82d651d525fa 2026-05-29 Warnings Exact identifier application number: M014 Meijer Earwax Removal Kit CARBAMIDE PEROXIDE Meijer Distribution Inc. a5f7bd55-55c3-4b0e-a16c-33bbea40536a 2026-05-29 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. d8fd8102-114f-415d-9083-f98a63f9d1b3 2026-05-29 Warnings Exact identifier application number: M014 Menthol Pain Relieving Gel PAIN RELIEVING GEL NeilMed Pharmaceuticals Inc 513a206c-bbf6-3e51-e063-6294a90adf7a 2026-05-07 Warnings Exact identifier application number: M014 ear drops CARBAMIDE PEROXIDE 6.5% Bionpharma Inc. e8bcf92c-ad32-49d5-e053-2995a90ae0c6 2026-04-27 Warnings Exact identifier application number: M014 Freskaro Earwax Removal Aid CARBAMIDE PEROXIDE 6.50% KIT Pharma Nobis, LLC 4f5967ee-bc05-341c-e063-6394a90a35c6 2026-04-15 Warnings Exact identifier application number: M014 GoodSense Ear Wax Removal Kit CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 9a4198d2-cbea-466a-a252-d5c63d9ea0c1 2026-04-09 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 52f733a7-1301-4078-9267-5ce95b006ccc 2026-04-09 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 0187-1660-06 00187166006 1 TUBE in 1 CARTON (0187-1660-06) / 170.1 g in 1 TUBE 1 tube 2012-01-01 0000-00-00 No No Current