FDA.reportPublic FDA data

Readybath TPC

Product NDC
53329-060
11-digit product format
533290060
Labeler code
53329
Product ID
53329-060_499e599b-a3d7-386d-e063-6294a90a461e
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CLOTH
Route
TOPICAL
Labeler
Medline Industries, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Marketing end
2027-06-30
Substance
DIMETHICONE
Active strength
.544 g/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
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
Readybath TPC
Brand name suffix
Total Perineal Care

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE.544 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43a3f0f7-f76f-434d-a21f-7eaa3638913dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-060-09Readybath TPCTotal Perineal Care3 in 1 PACKAGECLOTH37

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1OREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
DimethiconeACTIVE MOIETY92RU3N3Y1OREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7READYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RREADYBATH TPC (DIMETHICONE) CLOTH READYBATH TPC (DIMETHICONE) CLOTH READYCLEANSE (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH ALOETOUCH (DIMETHICONE) CLOTH READYFLUSH XLARGE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-060READYBATH TPC TOTAL PERINEAL CARE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20241204_43a3f0f7-f76f-434d-a21f-7eaa3638913d.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 24 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERADEX-EPETROLATUM AND LANOLINABBE Laboratories, Inc.00100102-c245-4b63-a4ff-794cacda6f172026-01-24WarningsExact identifier
application number: M016
HydrocortisoneDRS. HYDROCORTISONEOL PHARMA TECH,LLCb0eac8f3-bb80-6563-e053-2995a90a83c92026-01-22WarningsExact identifier
application number: M016
Eczema Reliegf Skin Protectant EQBCOLLOIDAL OATMEAL 2%Walmart37132a0d-37c5-4b21-9673-5f853b3a62482026-01-20WarningsExact identifier
application number: M016
Skin Relief CreamHYDROCORTISONESpa de Soleil0a90b77a-4be4-71c5-e063-6294a90a8e412026-01-20WarningsExact identifier
application number: M016
Cold Sore BandageCOLD SORE BANDAGEShenzhen Hengdasheng Technology Co., Ltd47f588a2-a69b-cffe-e063-6294a90a0ed42026-01-17WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.48793a50-89a7-dba9-e063-6394a90a70562026-01-16WarningsExact identifier
application number: M016
HAND SANITIZERHAND SANITIZERGuangdong bangze medicine co., ltd40018618-8f95-f6db-e063-6394a90ac7dd2026-01-16WarningsExact identifier
application number: M016
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKINDIMETHICONESolvChem, Inc.da12ac2c-1af9-47b1-aa5f-77acb48535ba2026-01-16WarningsExact identifier
application number: M016
Walgreens Vitamin A and D skin protectantLANOLIN, PETROLATUMWalgreen Company9aa6c7f2-0923-4d51-8b9b-63f9a724937a2026-01-15WarningsExact identifier
application number: M016
INCONTINENCE CARE WIPEDIMETHICONECardinal Health 200, Inc.1ac34c94-9e3b-45f2-ba19-a07dcd3941dd2026-01-15WarningsExact identifier
application number: M016
Alcohol Hand SanitizerALCOHOL HAND SANITIZERGuangdong bangze medicine co., ltd2e8b5afe-6ff8-3e9b-e063-6394a90ad7032026-01-14WarningsExact identifier
application number: M016
Alcohol SanitizerALCOHOL SANITIZER SPRAYGuangdong bangze medicine co., ltd2e9db49b-35ce-00d5-e063-6294a90acf352026-01-14WarningsExact identifier
application number: M016
GG XEROZINE 15SKIN PROTECTANTGERI-GENTLE CORPORATIONe6881c6d-f584-26d0-e053-2995a90a38732026-01-14WarningsExact identifier
application number: M016
Medpura Zinc Oxide 20%MEDPURA ZINC OXIDE 20%Akron Pharma Inc.3a63aaea-087e-4115-8478-64d416e6085f2026-01-14WarningsExact identifier
application number: M016
Walgreens Baby PetroleumPETROLATUMWalgreen Companye79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d2026-01-14WarningsExact identifier
application number: M016
Walgreens Cocoa Butter JellyPETROLEUMWalgreens32b84286-471a-4d15-80fb-2f516dc1d6ea2026-01-14WarningsExact identifier
application number: M016
Hydrating Healing Skin ProtectantPETROLATUM OINTMENTCVS Pharmacyc129c2b0-10d5-4b5d-ac5c-2e2512e612792026-01-14WarningsExact identifier
application number: M016
Multi-Purpose Skin ProtectantA AND D OINTMENTCVS Pharmacy60bd0095-25d3-44af-9502-0c63b3d25e662026-01-14WarningsExact identifier
application number: M016
Kenkoderm Eczema Honey Intensive Soothing BalmKENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALMGuangzhou Ariel Biotech Co., Ltd.48652b9c-4063-cc16-e063-6394a90a3b862026-01-14WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-060-09533290060093 CLOTH in 1 PACKAGE (53329-060-09) 3 cloth2007-01-012027-06-30NoNoHistorical