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 6 of 68 · 1,357 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
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

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