Dimopair

Product NDC
59088-623
11-digit product format
590880623
Labeler code
59088
Product ID
59088-623_237334e4-0b88-c4b2-e063-6394a90a5540
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-29
Substance
DIMETHICONE
Active strength
50 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
59088-623_237334e4-0b88-c4b2-e063-6394a90a5540
SPL ID
237334e4-0b88-c4b2-e063-6394a90a5540
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
Dimopair
Generic name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Marketing start
2023-03-29
Marketing category
OTC MONOGRAPH DRUG
Application number
M016
Pharmacologic classes
Skin Barrier Activity [PE]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
DIMETHICONE50 mg/mL

openFDA Harmonized Identifiers

FieldValues
Unii92RU3N3Y1O
Rxcui259090
Spl Set Iddc16af56-b97d-c17f-e053-2995a90a55a0
Manufacturer NamePureTek Corporation

openFDA Package Details

Package NDCDescriptionMarketing startSample
59088-623-08118 mL in 1 TUBE (59088-623-08)2023-03-29No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
92RU3N3Y1ODIMETHICONE9006-65-9DIMETHICONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-623-0859088062308118 mL in 1 TUBE (59088-623-08) 118 ml2023-03-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DimopairPureTek Corporation2024-10-01HUMAN OTC DRUG LABEL3