FDA.reportPublic FDA data

Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant

Product NDC
43128-035
11-digit product format
431280035
Labeler code
43128
Product ID
43128-035_8152e11f-403b-f83c-e053-2a91aa0a0f4d
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
NDC National Distribution & Contracting, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-07
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43128-035-022021-01-29C16284748780-1ba0f9c33-4311-a910-e053-dadaa90a0b85Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43128-035-02Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant1 in 1 PACKAGECREAM14
43128-035-02Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant118 mL in 1 TUBECREAM1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43128-035PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.]4Legacy NDC, 2 package rows20190208_d4f3df9f-94c4-49c5-94cd-4b97ec254993.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244642dimethicone 2 % Topical CreamPSNd4f3df9f-94c4-49c5-94cd-4b97ec2549934
244642dimethicone 20 MG/ML Topical CreamSCDd4f3df9f-94c4-49c5-94cd-4b97ec2549934
244642dimethicone 2 % Topical CreamSYd4f3df9f-94c4-49c5-94cd-4b97ec2549934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43128-035-02431280035021 in 1 PACKAGEHistorical