Personal Cleansing with Dimethicone

Product NDC
63517-126
11-digit product format
635170126
Labeler code
63517
Product ID
63517-126_2a4492f5-13ea-333d-e063-6394a90aa026
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Cardinal Health 200, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
Substance
DIMETHICONE
Active strength
32 mg/mL
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
Personal Cleansing with Dimethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE32 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039149Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f9a1a90-ab12-4911-b8c2-df200b0dde5bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-126-21Personal Cleansing with Dimethicone42 in 1 PACKETCLOTH425
63517-126-21Personal Cleansing with Dimethicone1 in 1 POUCHCLOTH15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-126PERSONAL CLEANSING WITH DIMETHICONE (DIMETHICONE) CLOTH [CARDINAL HEALTH 200, INC]5Current NDC, Legacy NDC, 2 package rows20241228_3f9a1a90-ab12-4911-b8c2-df200b0dde5b.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 28 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TENA PROSKIN BARRIERDIMETHICONEEssity HMS North America Inc118bf2df-ee7b-454f-9c0b-2697dc8262682025-12-21WarningsExact identifier
application number: M016
Geri Care Medicated PadsWITCH HAZELGeri-Care Pharmaceuticals, Corp2d020e79-2bcf-ba8f-e063-6394a90a6fda2025-12-19WarningsExact identifier
application number: M016
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and ApricotCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19ba97d-5c47-e98f-e053-2995a90afc232025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Pink GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyd21c05e4-c4e6-de6e-e053-2995a90a38bb2025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling CucumberCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1a9cc960-782e-4f0c-e063-6394a90a32f62025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Birthday HydrationCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2759f74e-cf64-8bbc-e063-6394a90ace212025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Winter MintCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company275ece2b-deb9-c95b-e063-6394a90aa9392025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27722bd0-0a07-53ef-e063-6294a90ae9912025-12-18WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter CitrusCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27723670-70c6-5462-e063-6294a90a84f32025-12-18WarningsExact identifier
application number: M016
Sprayable Diaper Rash CreamZINC OXIDEThe Honest Company, Inc.e0f28717-a87a-2759-e053-2995a90abe7a2025-12-18WarningsExact identifier
application number: M016
Vitamin A DPETROLATUMDynarex Corporationdb4df818-cb0c-434d-e053-2a95a90aaa192025-12-18WarningsExact identifier
application number: M016
Everyday Diaper Rash CreamZINC OXIDEThe Honest Company, Incdfdc5021-9551-3867-e053-2995a90af52b2025-12-16WarningsExact identifier
application number: M016
Aquaphor Healing Fast Relief Diaper RashZINC OXIDEBeiersdorf Inc887e3566-ec5d-4474-83c6-edcc0732f8d62025-12-16WarningsExact identifier
application number: M016
Aquaphor Healing Balm StickPETROLATUMBeiersdorf Incd1670ac6-1672-4b86-e053-2995a90aef602025-12-16Exact identifier
application number: M016
Eucerin Eczema Relief HydrogelOATMEALBeiersdorf Inc15c673fa-739e-a14a-e063-6394a90a30de2025-12-16WarningsExact identifier
application number: M016
EELHOE Supports Healthy Hearing DropsGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.45f838e3-b643-2fdd-e063-6394a90a62f42025-12-15WarningsExact identifier
application number: M016
Crash CreamWHITE PETROLATUMClaridei Laboratories01580e8e-93f3-afeb-e063-6294a90a6cbc2025-12-15WarningsExact identifier
application number: M016
TrueLipids 1% Hydrocortisone Barrier CreamHYDROCORTISONEClaridei Laboratories037395dc-5b96-052e-e063-6394a90a26e42025-12-15WarningsExact identifier
application number: M016
TrueLipids Boo-Boo and Bum Balm CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27bf896e-5614-42f3-e063-6394a90ac3232025-12-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039149dimethicone 3.2 % Medicated PadPSN3f9a1a90-ab12-4911-b8c2-df200b0dde5b5
1039149dimethicone 32 MG/ML Medicated PadSCD3f9a1a90-ab12-4911-b8c2-df200b0dde5b5
1039149dimethicone 3.2 % Medicated PadSY3f9a1a90-ab12-4911-b8c2-df200b0dde5b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-126-216351701262142 POUCH in 1 PACKET (63517-126-21) / 1 PATCH in 1 POUCH / 28.59 mL in 1 PATCH42 pouch2019-05-150000-00-00NoNoCurrent