FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct0187-1660EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0187-16600187-1660-06EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
DIMETHICONE1.7 g/170.1g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200010Internal RxNorm lookup
826807Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c8dc616-20c1-4d33-8a89-9bcdb22b35c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-1660-06TheraSeal170.1 g in 1 TUBECREAM170.14
0187-1660-06TheraSeal1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-1660-06GM - Gram0187-1660e155a7f3-9b28-4838-8789-bd9b308288c812015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1OTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
DimethiconeACTIVE MOIETY92RU3N3Y1OTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Hexyl LaurateINACTIVE INGREDIENT4CG9F9W01QTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ImidureaINACTIVE INGREDIENTM629807ATLTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7THERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RTHERASEAL (DIMETHICONE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-1660THERASEAL (DIMETHICONE) CREAM [BAUSCH HEALTH US, LLC]4Current NDC, Legacy NDC, 2 package rows20241019_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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200010dimethicone 1 % Topical CreamPSN2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
826807TheraSeal Hand Protection 1 % Topical CreamPSN2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
826807dimethicone 10 MG/ML Topical Cream [TheraSeal Hand Protection]SBD2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
200010dimethicone 10 MG/ML Topical CreamSCD2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
200010dimethicone 1 % Topical CreamSY2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
826807TheraSeal Hand Protection 1 % Topical CreamSY2c8dc616-20c1-4d33-8a89-9bcdb22b35c84
826807TheraSeal Hand Protection 10 MG/ML Topical CreamSY2c8dc616-20c1-4d33-8a89-9bcdb22b35c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-1660-06001871660061 TUBE in 1 CARTON (0187-1660-06) / 170.1 g in 1 TUBE1 tube2012-01-010000-00-00NoNoCurrent