Comfort Shield Barrier

Product NDC: 53462-915
11-digit product format: 534620915
Labeler code: 53462
Product ID: 53462-915_54ee06dc-1e51-3f8a-e063-6294a90a1fb0
Type: HUMAN OTC DRUG
Nonproprietary name: dimethicone
Dosage form: CLOTH
Route: TOPICAL
Labeler: Sage Products LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-01-01
Substance: DIMETHICONE
Active strength: 30 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 package	package	53462-915	53462-915-62	D	Discontinued by firm		2026-10-20
excluded package	package	53462-915	53462-915-81	D	Discontinued by firm		2026-10-20

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 · 13 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	53462-915-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	53462-915-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	53462-915-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	53462-915-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	53462-915-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	53462-915-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	53462-915-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	53462-915-62	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	53462-915-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	53462-915-62	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	53462-915-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	53462-915-62	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	53462-915-62	`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: Comfort Shield Barrier
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	30 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
968663	Internal RxNorm lookup
1088604	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
cc08f571-84ae-4c2f-b09d-a83a8efc39f5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53462-915-50	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-02-22	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-50	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-51	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-62	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-80	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	Comfort Shield Barrier Cream Cloths
53462-915-81	2022-01-28	Comfort Shield Barrier Cream Cloths

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53462-915-24	Comfort Shield Barrier	24 g in 1 APPLICATOR	CLOTH	24	16
53462-915-24	Comfort Shield Barrier	24 in 1 PACKAGE	CLOTH	24	16
53462-915-50	Comfort Shield Barrier	26 g in 1 APPLICATOR	CLOTH	26	16
53462-915-50	Comfort Shield Barrier	3 in 1 PACKAGE	CLOTH	3	16
53462-915-51	Comfort Shield Barrier	3 in 1 PACKAGE	CLOTH	3	16
53462-915-51	Comfort Shield Barrier	19 g in 1 APPLICATOR	CLOTH	19	16
53462-915-62	Comfort Shield Barrier	24 g in 1 APPLICATOR	CLOTH	24	16
53462-915-62	Comfort Shield Barrier	24 in 1 PACKAGE	CLOTH	24	16
53462-915-80	Comfort Shield Barrier	27 g in 1 APPLICATOR	CLOTH	27	16
53462-915-80	Comfort Shield Barrier	8 in 1 PACKAGE	CLOTH	8	16
53462-915-81	Comfort Shield Barrier	19 g in 1 APPLICATOR	CLOTH	19	16
53462-915-81	Comfort Shield Barrier	8 in 1 PACKAGE	CLOTH	8	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53462-915-50	EA - Each	53462-915	86d72459-ae42-4f14-82c1-9a3562488a17	1	2012-07-24
53462-915-51	EA - Each	53462-915	8f65a50a-b111-45b6-92fc-cb0281b43583	1	2012-07-24
53462-915-60	EA - Each	53462-915	5e281b48-6ba9-471a-a477-dd3fed32e90c	1	2012-07-24
53462-915-80	EA - Each	53462-915	25b8c726-486d-4f6d-bc84-a120976ca2bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
dimethicone	ACTIVE MOIETY	92RU3N3Y1O	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
chlorhexidine gluconate	INACTIVE INGREDIENT	MOR84MUD8E	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
hydroxyethyl cellulose (4000 MPA.S at 1%)	INACTIVE INGREDIENT	ZYD53NBL45	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
PEG-100 stearate	INACTIVE INGREDIENT	YD01N1999R	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
PPG-15 STEARYL ETHER	INACTIVE INGREDIENT	1II18XLS1L	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6
water	INACTIVE INGREDIENT	059QF0KO0R	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53462-915	COMFORT SHIELD BARRIER (DIMETHICONE) CLOTH [SAGE PRODUCTS LLC]	15	Current NDC, Legacy NDC, 12 package rows	20241120_cc08f571-84ae-4c2f-b09d-a83a8efc39f5.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Skin Mercy Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	4bac19f3-13bb-8d18-e063-6394a90aa393	2026-02-25	Warnings	Exact identifier application number: M016
Skin Mercy Intense Recovery Cream	COLLOIDAL OATMEAL	Cultskin Apothecary, Inc.	468f21c6-2d6f-1654-e063-6394a90ab2f5	2026-02-25	Warnings	Exact identifier application number: M016
Magnet Eye Sheet Mask	EYE MASK	Guangdong Bisutang Biotechnology Co., LTD	4a0a84d4-4024-5ea7-e063-6394a90a2b6c	2026-02-24	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Family Dollar Stores, Inc	ac7da793-8a39-4b47-b075-a4c4820cadad	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Family Dollar Stores, Inc	1a03331e-3676-451c-be22-9a547e8ae6e2	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Family Dollar Stores, Inc	7e64a424-afdb-4eb9-b6af-7b8123f1e207	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	H E B	e6154e44-d7b2-429c-9bc7-5c064220d3fb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	H E B	f0b31d52-2903-487a-aa70-0dbdf4c4d7e7	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	ff79e42c-da3f-4aec-acf4-cc26e10a1d08	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	H E B	a8ad595a-c811-4534-82e0-9a01085b4b1e	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	H E B	ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	460802cc-c1b9-41cb-afe3-ca4078175efb	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	H E B	2dd85211-0840-4d0d-8ba7-ea6184a50942	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Meijer, Inc.	12867b23-b203-4bd7-af6d-efddeead26be	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	c7a4b7f2-4de9-470c-9f5b-0142bd935137	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Better Living Brands, LLC	75cb8f17-6ef2-403e-ab6e-d8e1e8168ec8	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
WHITE PETROLATUM	PETROLATUM	Sion Biotext Medical Ltd	53ca3aeb-1d5d-4964-adb5-1cfa901642da	2026-02-23	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Better Living Brands, LLC	1d491635-9605-44fa-9860-ea23e4e8b21c	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Better Living Brands, LLC	ba50f2b2-aff8-42cd-8af0-369060a901fb	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M016
Oatmeal	DIMETHICONE	Better Living Brands, LLC	d28c5a60-0597-424f-bf7f-08dca39b22f5	2026-02-23	Warnings, Adverse reactions	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
1088604	Comfort Shield 3 % Medicated Pad	PSN	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
968663	dimethicone 3 % Medicated Pad	PSN	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
1088604	dimethicone 30 MG/ML Medicated Pad [Comfort Shield]	SBD	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
968663	dimethicone 30 MG/ML Medicated Pad	SCD	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
1088604	Comfort Shield 3 % Medicated Pad	SY	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
1088604	Comfort Shield 30 MG/ML Medicated Pad	SY	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
968663	dimethicone 3 % Medicated Pad	SY	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16
968663	dimethicone 3 % Wipe	SY	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53462-915-24	53462091524	24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR	24 applicator	2023-12-11		No	No	Current
53462-915-50	53462091550	3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR	3 applicator	1990-01-01	0000-00-00	No	No	Current
53462-915-51	53462091551	3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR	3 applicator	1990-01-01	0000-00-00	No	No	Current
53462-915-62	53462091562	24 APPLICATOR in 1 PACKAGE (53462-915-62) > 24 g in 1 APPLICATOR	24 applicator	1990-01-01	0000-00-00	No	No	Current
53462-915-80	53462091580	8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR	8 applicator	1990-01-01	0000-00-00	No	No	Current
53462-915-81	53462091581	8 APPLICATOR in 1 PACKAGE (53462-915-81) > 19 g in 1 APPLICATOR	8 applicator	1990-01-01	0000-00-00	No	No	Current