FDA.reportPublic FDA data

Readyflush Protect Wipes

Product NDC
53329-075
Requested package NDC
53329-075-58
11-digit product format
533290075
Labeler code
53329
Product ID
53329-075_5dfafadc-a2aa-9e08-e063-6294a90a5dc0
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
2012-08-01
Substance
DIMETHICONE
Active strength
3.2 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
Readyflush Protect Wipes
Brand name suffix
Fragrance Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE3.2 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-075-58Readyflush Protect WipesFragrance Free9.2 mL in 1 APPLICATORCLOTH9.27
53329-075-58Readyflush Protect WipesFragrance Free24 in 1 PACKAGECLOTH247
53329-075-62Readyflush Protect WipesFragrance Free9.2 mL in 1 APPLICATORCLOTH9.27
53329-075-62Readyflush Protect WipesFragrance Free60 in 1 PACKAGECLOTH607

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7READYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM4READYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENT5Q87K461JOREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREADYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-075READYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 4 package rows20241204_743d21bd-c40a-4415-ad97-0d8aa99a8af7.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Mercy Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.4bac19f3-13bb-8d18-e063-6394a90aa3932026-02-25WarningsExact identifier
application number: M016
Skin Mercy Intense Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.468f21c6-2d6f-1654-e063-6394a90ab2f52026-02-25WarningsExact identifier
application number: M016
Magnet Eye Sheet MaskEYE MASKGuangdong Bisutang Biotechnology Co., LTD4a0a84d4-4024-5ea7-e063-6394a90a2b6c2026-02-24WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEH E Bf0b31d52-2903-487a-aa70-0dbdf4c4d7e72026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEH E Ba8ad595a-c811-4534-82e0-9a01085b4b1e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALH E Bce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMeijer, Inc.12867b23-b203-4bd7-af6d-efddeead26be2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.c7a4b7f2-4de9-470c-9f5b-0142bd9351372026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMBetter Living Brands, LLC75cb8f17-6ef2-403e-ab6e-d8e1e8168ec82026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEBetter Living Brands, LLC1d491635-9605-44fa-9860-ea23e4e8b21c2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMBetter Living Brands, LLCba50f2b2-aff8-42cd-8af0-369060a901fb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
OatmealDIMETHICONEBetter Living Brands, LLCd28c5a60-0597-424f-bf7f-08dca39b22f52026-02-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039149dimethicone 3.2 % Medicated PadPSN743d21bd-c40a-4415-ad97-0d8aa99a8af77
1039149dimethicone 32 MG/ML Medicated PadSCD743d21bd-c40a-4415-ad97-0d8aa99a8af77
1039149dimethicone 3.2 % Medicated PadSY743d21bd-c40a-4415-ad97-0d8aa99a8af77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-075-585332900755824 APPLICATOR in 1 PACKAGE (53329-075-58) / 9.2 mL in 1 APPLICATOR24 applicator2012-08-010000-00-00NoNoCurrent