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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact 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