FDA.reportPublic FDA data

Remedy Barrier Cream Cloths

Product NDC
53329-078
11-digit product format
533290078
Labeler code
53329
Product ID
53329-078_0f51b38f-83f0-3071-e063-6294a90a58d5
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CLOTH
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-19
Substance
DIMETHICONE
Active strength
3.6 g/100mL
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
Remedy Barrier Cream Cloths
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE3.6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui1534833

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-078-02Remedy Barrier Cream Cloths6.9 mL in 1 APPLICATORCLOTH6.911
53329-078-02Remedy Barrier Cream Cloths3 in 1 PACKAGECLOTH311
53329-078-76Remedy Barrier Cream Cloths8 in 1 PACKAGECLOTH811
53329-078-76Remedy Barrier Cream Cloths17 mL in 1 APPLICATORCLOTH1711
53329-078-91Remedy Barrier Cream Cloths6.9 mL in 1 APPLICATORCLOTH6.911
53329-078-91Remedy Barrier Cream Cloths48 in 1 PACKAGECLOTH4811

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
7-DEHYDROCHOLESTEROLINACTIVE INGREDIENTBK1IU07GKFREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
C12-20 ALKYL GLUCOSIDEINACTIVE INGREDIENTK67N5Z1RUAREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CAMELLIA SINENSIS FLOWERINACTIVE INGREDIENT9I2BJY2J17REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CLOVEINACTIVE INGREDIENTK48IKT5321REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225BREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
COCONUT ALCOHOLINACTIVE INGREDIENT13F4MW8Y9KREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
DULSEINACTIVE INGREDIENT7832HOY4ZQREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ETHYLENE BRASSYLATEINACTIVE INGREDIENT9A87HC7RODREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
METHYL DIHYDROJASMONATE (SYNTHETIC)INACTIVE INGREDIENT3GW44CIE3YREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
OMEGA-3 FATTY ACIDSINACTIVE INGREDIENT71M78END5SREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SOYBEAN OILINACTIVE INGREDIENT241ATL177AREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SQUALANEINACTIVE INGREDIENTGW89575KF9REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
UREAINACTIVE INGREDIENT8W8T17847WREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
VANILLAINACTIVE INGREDIENTQ74T35078HREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2
YEASTINACTIVE INGREDIENT3NY3SM6B8UREMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-078REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 6 package rows20240120_00e0cd4a-6049-408a-ab3f-9edf97e6438a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1534833dimethicone 3.6 % Medicated PadPSN00e0cd4a-6049-408a-ab3f-9edf97e6438a11
1534833dimethicone 36 MG/ML Medicated PadSCD00e0cd4a-6049-408a-ab3f-9edf97e6438a11
1534833dimethicone 3.6 % WipeSY00e0cd4a-6049-408a-ab3f-9edf97e6438a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-078-02533290078023 APPLICATOR in 1 PACKAGE (53329-078-02) / 6.9 mL in 1 APPLICATOR3 applicator2013-12-190000-00-00NoNoCurrent
53329-078-76533290078768 APPLICATOR in 1 PACKAGE (53329-078-76) / 17 mL in 1 APPLICATOR8 applicator2013-12-190000-00-00NoNoCurrent
53329-078-915332900789148 APPLICATOR in 1 PACKAGE (53329-078-91) > 6.9 mL in 1 APPLICATOR48 applicator2013-12-190000-00-00NoNoCurrent