Dimethicone

Product NDC
76162-496
11-digit product format
761620496
Labeler code
76162
Product ID
76162-496_4ab96f1f-2e42-3a02-e063-6394a90a7001
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
Substance
DIMETHICONE
Active strength
12 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dimethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE12 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui876980

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-496-44Dimethicone532 mL in 1 BOTTLE, PLASTICLOTION5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-496DIMETHICONE LOTION [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20250406_f37f17f7-f084-4b74-8361-178d2315a476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876980dimethicone 1.2 % Topical LotionPSNf37f17f7-f084-4b74-8361-178d2315a4763
876980dimethicone 12 MG/ML Topical LotionSCDf37f17f7-f084-4b74-8361-178d2315a4763
876980dimethicone 1.2 % Topical LotionSYf37f17f7-f084-4b74-8361-178d2315a4763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-496-4476162049644532 mL in 1 BOTTLE, PLASTIC (76162-496-44) 532 ml2024-04-18NoNoCurrent