Barrier Protectant Cream

Product NDC: 63517-003
11-digit product format: 635170003
Labeler code: 63517
Product ID: 63517-003_3ce34f81-6708-c228-e063-6394a90a59d3
Type: HUMAN OTC DRUG
Nonproprietary name: Barrier Cream
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Cardinal Health
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-15
Substance: MENTHOL; ZINC OXIDE
Active strength: 1; 200 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 2 · 68 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
2025-04-01 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	63517-003-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63517-003-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63517-003-32	`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	63517-003-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63517-003-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63517-003-32	`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	63517-003-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63517-003-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63517-003-32	`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	63517-003-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63517-003-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63517-003-32	`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	63517-003-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63517-003-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63517-003-32	`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	63517-003-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63517-003-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63517-003-32	`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	63517-003-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63517-003-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63517-003-32	`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	63517-003-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63517-003-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63517-003-32	`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	63517-003-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63517-003-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63517-003-32	`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	63517-003-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63517-003-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63517-003-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63517-003-34	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63517-003-31	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63517-003-32	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63517-003-34	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63517-003-31	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63517-003-32	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63517-003-34	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63517-003-31	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63517-003-32	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63517-003-34	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63517-003-31	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63517-003-32	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63517-003-34	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63517-003-31	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63517-003-32	`86f5da6cb304…`	`a595104c45d7…`

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: Barrier Protectant Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 mg/g
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
539d9aac-75cf-4efd-bb3e-b465563304ca	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63517-003-31	2025-08-21	Barrier Protectant Cream
63517-003-32	2025-08-21	Barrier Protectant Cream
63517-003-34	2025-08-21	Barrier Protectant Cream
63517-003-31	2021-07-23	Barrier Protectant Cream
63517-003-32	2021-07-23	Barrier Protectant Cream
63517-003-34	2021-07-23	Barrier Protectant Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63517-003-31	Barrier Protectant Cream	113 g in 1 TUBE	OINTMENT	113	4
63517-003-32	Barrier Protectant Cream	57 g in 1 TUBE	OINTMENT	57	4
63517-003-34	Barrier Protectant Cream	5 g in 1 POUCH	OINTMENT	5	4
63517-003-34	Barrier Protectant Cream	150 in 1 BOX	OINTMENT	150	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63517-003	BARRIER PROTECTANT CREAM (BARRIER CREAM) OINTMENT [CARDINAL HEALTH]	3	Current NDC, Legacy NDC, 4 package rows	20200131_539d9aac-75cf-4efd-bb3e-b465563304ca.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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Meijer Distribution Inc	14319ba4-3bce-497c-a380-65bd24defc5d	2024-10-17	Warnings	Exact identifier application number: M015
equate hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	581dd76f-d052-4448-8139-9a2e31891b25	2024-10-17	Warnings	Exact identifier application number: M015
Equate Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	81ecb091-38da-4b3e-a0a1-b4986b97ee09	2024-10-16	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	5c81d564-f786-46e1-af8b-f47521fbae60	2024-10-16	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Topco Associates LLC	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	2024-10-16	Warnings	Exact identifier application number: M015
Basic Care Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Amazon.com Services LLC	fe675174-fc95-4dd7-bd39-c209c6ce0f6c	2024-10-16	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Meijer Distribution Inc	fb170371-2e5d-43ca-a259-538a973ee3b8	2024-10-15	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Topco Associates LLC	5e13da07-48cf-40bc-bb11-fd891886cbea	2024-10-14	Warnings	Exact identifier application number: M015
hemorrhoidal maximum strength pain relief	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Kroger Company	3c8f90e2-fecf-4439-9faa-81a32ffe4753	2024-09-26	Warnings	Exact identifier application number: M015
equate hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Wal-Mart Stores Inc	5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d	2024-09-26	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal Pain Relief	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Walgreens	e79ed7ae-0d06-2f88-e053-2995a90a1e35	2024-09-20	Warnings	Exact identifier application number: M015
hemorrhoidal relief	COCOA BUTTER, PHENYLEPHRINE HCL	Rite Aid Corporation	ddafbdca-32c2-49c1-83d3-35b4155958c9	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Rite Aid Corporation	8e1f223a-a3a0-4837-9847-2a3939fcc595	2024-08-15	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bryant Ranch Prepack	485fd02f-bfea-41d0-90a1-f12fcfeb2a15	2024-08-14	Warnings	Exact identifier application number: M015
Up and Up Hemorrhoid MAX STRENGTH	14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUM	Target Corporation	867677b5-fd1d-449e-966e-1de0b5c98afb	2024-08-08	Warnings	Exact identifier application number: M015
Soothing Hemorrhoidal Wipes 50 Witch Hazel	WITCH HAZEL	The Honey Pot Company LLC	1ea202f5-e228-b3f2-e063-6294a90a16c1	2024-08-01	Warnings	Exact identifier application number: M015
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Exact identifier application number: M015
Bunnies Bum Soothing Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	FloCal Distributors LLC	1c81582c-7ece-182f-e063-6294a90a8fbc	2024-07-05	Warnings	Exact identifier application number: M015
MegaBabe Butt Stuff Hemorrhoidal	COCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	MEGABABE, LLC	01c156ff-69f9-4d5e-a9ea-abbc52d4afff	2024-06-12	Warnings	Exact identifier application number: M015
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63517-003-31	63517000331	113 g in 1 TUBE (63517-003-31)	113 g	2015-01-15	0000-00-00	No	No	Current
63517-003-32	63517000332	57 g in 1 TUBE (63517-003-32)	57 g	2015-01-15	0000-00-00	No	No	Current
63517-003-34	63517000334	150 POUCH in 1 BOX (63517-003-34) / 5 g in 1 POUCH	150 pouch	2015-01-15	0000-00-00	No	No	Current