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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	4eb3c9ac-268a-5246-e054-00144ff88e88	2025-06-09	Warnings	Exact identifier application number: M015
Bunnies Bum Anorectal Numbing	LIDOCAINE	FloCal Distributors LLC	3712e151-d171-1c5d-e063-6294a90a36c0	2025-06-08	Warnings	Exact identifier application number: M015
RECOVERY Numbing	LIDOCAINE HCL	Renu Laboratories, LLC	e4e05cae-56a6-b2b3-e053-2a95a90a104b	2025-06-06	Warnings	Exact identifier application number: M015
Hemorrohoid Master Cream	LIDOCAINE, PHENYLEPHRINE HCL	Ebanel Laboratories, Inc.	36eccc74-107e-3914-e063-6294a90a1856	2025-06-06	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	36c9988b-9e61-ebbf-e063-6394a90a4114	2025-06-04	Warnings	Exact identifier application number: M015
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE HCL	Clinical Resolution Laboratory, Inc.	36caf20d-116a-f86a-e063-6294a90a7b62	2025-06-04	Warnings	Exact identifier application number: M015
Quick Numb	LIDOCAINE	Clinical Resolution Laboratory, Inc.	351b95a6-e038-d9aa-e063-6294a90a4172	2025-05-29	Warnings	Exact identifier application number: M015
Dibucaine Topical Anesthetic 1% Hemorrhoidal	DIBUCAINE	Rugby Laboratories Inc.	f23c8cd1-98f9-41cd-84d4-cf01c2ede29a	2025-05-29	Warnings	Exact identifier application number: M015
The Femme Fix Hemorrhoid Treatment	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	5217b5d9-b835-4428-a6b3-e6b255630742	2025-05-27	Warnings	Exact identifier application number: M015
MAXOCAINE Topical Anesthetic Anorectal	LIDOCAINE	PRIME COMMERCE, LLC	26e8c867-8cb8-4a25-91b1-da45a1edd09a	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Ebanel Laboratories, Inc.	35107403-55ae-c627-e063-6394a90a0b5c	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	350e4d5e-dac7-ae4e-e063-6394a90a76b4	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE 5%	Ebanel Laboratories, Inc	350fd302-8fd5-5288-e063-6294a90aa382	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	35095bed-0e91-c44a-e063-6294a90add6e	2025-05-27	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	a0411950-c6ee-4427-acb6-3cef58b0e93e	2025-05-15	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Clinical Resolution Laboratory, Inc.	cfcb839d-47b4-4925-bb30-97b64d20d2b3	2025-05-15	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Clinical Resolution Laboratory, Inc.	65d3b614-361d-4fb9-9583-a95be754bc82	2025-05-15	Warnings	Exact identifier application number: M015
Chamosyn	BARRIER CREAM	Links Medical Products	f9dfb2d7-4684-4525-994e-1e0ff90413d9	2025-05-08	Warnings	Exact identifier application number: M015
LANOZEM HEMORRHOIDAL	MENTHOL, PETROLATUM	Sod-e Biotech Ltd	34901e83-8f24-8460-e063-6394a90a2744	2025-05-07	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	96d2e0e7-2de0-4660-9ffd-9edb2ad224d8	2025-04-18	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