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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui200010, 826807

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

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