INCONTINENCE CARE WIPE

Product NDC: 63517-131
11-digit product format: 635170131
Labeler code: 63517
Product ID: 63517-131_48735d8d-1680-1895-e063-6294a90afb91
Type: HUMAN OTC DRUG
Nonproprietary name: DIMETHICONE
Dosage form: SWAB
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/g
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63517-131		D	Discontinued by firm		2026-10-23
excluded package	package	63517-131	63517-131-21	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63517-131-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63517-131-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63517-131-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63517-131-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63517-131-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63517-131-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63517-131-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63517-131-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63517-131-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63517-131-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63517-131-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63517-131-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: INCONTINENCE CARE WIPE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	32 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ac34c94-9e3b-45f2-ba19-a07dcd3941dd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63517-131-22	INCONTINENCE CARE WIPE	3 in 1 PACKET	SWAB	3		5
63517-131-22	INCONTINENCE CARE WIPE	1 in 1 POUCH	SWAB	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
PPG-15 STEARYL ETHER	INACTIVE INGREDIENT	1II18XLS1L	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63517-131	INCONTINENCE CARE WIPE (DIMETHICONE) SWAB [CARDINAL HEALTH 200, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241228_1ac34c94-9e3b-45f2-ba19-a07dcd3941dd.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 66 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Baby Soothe and Protect Cream	ALLANTOIN	Galderma Laboratories, L.P.	38254e03-3716-4e45-86b7-06430ebadc86	2023-11-22	Warnings	Exact identifier application number: M016
Cetaphil Baby Eczema Soothing	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b	2023-11-22	Warnings	Exact identifier application number: M016
EczemaHoneyBodyLotion	COLLOIDAL OATMEAL	Allure Labs	0a710be0-562e-8368-e063-6294a90a3b1b	2023-11-18	Warnings	Exact identifier application number: M016
Zinc Oxide	SKIN PROTECTANT	BluePoint Laboratories	d9b752e6-655a-19a6-e053-2995a90a9a37	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier application number: M016
DERMA SANTE Anti Eczema Cream	OATMEAL	Hope Science Inc.	1492a6ad-016c-4307-8286-5c564de9e160	2023-11-11	Warnings	Exact identifier application number: M016
M3 NATURALS Eczema Cream	OATMEAL	M3 Naturals LLC	45e2cdde-58fb-4eea-a54d-f53f9ad0d854	2023-11-11	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	53900588-5c9e-4164-816d-017bdbb0f31b	2023-11-11	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Max Strength	ZINC OXIDE	Geodis Logistics LLC	1b4fd6cb-f2dc-40a2-b958-e99caec91793	2023-11-10	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Original	ZINC OXIDE	Geodis Logistics LLC	97587458-4ca0-4de3-9bb9-148346d859c0	2023-11-10	Warnings	Exact identifier application number: M016
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039149	dimethicone 3.2 % Medicated Pad	PSN	1ac34c94-9e3b-45f2-ba19-a07dcd3941dd	5
1039149	dimethicone 32 MG/ML Medicated Pad	SCD	1ac34c94-9e3b-45f2-ba19-a07dcd3941dd	5
1039149	dimethicone 3.2 % Medicated Pad	SY	1ac34c94-9e3b-45f2-ba19-a07dcd3941dd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63517-131-21	63517013121	3 PACKAGE in 1 CARTON (63517-131-21) > 20 g in 1 PACKAGE	3 package	2015-08-21	0000-00-00	No	No	Current
63517-131-22	63517013122	3 POUCH in 1 PACKET (63517-131-22) / 1 PATCH in 1 POUCH / 52.93 g in 1 PATCH	3 pouch	2019-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INCONTINENCE CARE WIPE	Cardinal Health 200, Inc.	2026-01-15	HUMAN OTC DRUG LABEL	5
incontinence care wipe	Cardinal Health 200, Inc.	2021-12-09	HUMAN OTC DRUG LABEL	3