Remedy Barrier Cream Cloths

Product NDC
53329-074
11-digit product format
533290074
Labeler code
53329
Product ID
53329-074_5693e3a7-6102-0b96-e063-6294a90ab48f
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
2016-08-31
Substance
DIMETHICONE
Active strength
3.6 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Remedy Barrier Cream Cloths
Brand name suffix
Fragrance Free
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1534833Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00e0cd4a-6049-408a-ab3f-9edf97e6438aAvailable on FDA.report

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
53329-074-76Remedy Barrier Cream ClothsFragrance Free17 mL in 1 APPLICATORCLOTH1711
53329-074-76Remedy Barrier Cream ClothsFragrance Free8 in 1 PACKAGECLOTH811

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
53329-074REMEDY BARRIER CREAM CLOTHS (DIMETHICONE) CLOTH REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 2 package rows20240120_00e0cd4a-6049-408a-ab3f-9edf97e6438a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
ndc (product): 53329-074
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact identifier
application number: M016

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
53329-074-76533290074768 APPLICATOR in 1 PACKAGE (53329-074-76) / 17 mL in 1 APPLICATOR8 applicator2016-08-310000-00-00NoNoCurrent