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 37 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE ZOEUN SKIN TOTAL CARECOLLOIDAL OATMEAL, STURGEON EXTRACTSturgeonbio Co.,Ltd.42712685-64d4-0170-e063-6394a90a75d72025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total CleanserCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4275eecd-67bb-fb1c-e063-6294a90aa09a2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Mist TonerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42766f41-74bc-d19d-e063-6294a90aba532025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Y-Zone Feminine MoisturizerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42773426-f39f-bebe-e063-6394a90a73d92025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Eye CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42792a80-555b-e86c-e063-6294a90a2f302025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Night MaskCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42843691-8761-3f32-e063-6394a90a59bc2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact 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