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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mayinglong Hemorrhoidal	PETROLATUM, ZINC OXIDE	Mayinglong Pharmaceutical Group Co., Ltd.	b14192ea-1bf7-da6a-e053-2a95a90a5b5e	2023-12-08	Warnings	Exact identifier application number: M015
Hemorrhoidal cooling gel	PHENYLEPHRINE HCL, WITCH HAZEL	WALGREENS	03bbe258-e00d-13cc-e063-6394a90ae345	2023-12-05	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	WALGREENS	03bc5c1a-d493-5082-e063-6394a90ae87b	2023-12-05	Warnings	Exact identifier application number: M015
Bloop Hemorrhoid Relief Topical	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Three Nations Corp	0b6419e3-f1c7-bdfe-e063-6294a90a5d92	2023-11-30	Warnings	Exact identifier application number: M015
Bloop Fissure Healing Anorectal Topical	LIDOCAINE	Three Nations Corp	0b645092-ebc4-e4bb-e063-6294a90ad4cf	2023-11-30	Warnings	Exact identifier application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF	LIDOCAINE	ALPHA PLANTS INC	79fa4b89-382f-45fa-a792-90a9fe5bf573	2023-11-11	Warnings	Exact identifier application number: M015
BODY ACTION PRODUCTS Prolong Lubricating	BENZOCAINE	PRODUCT MAX GROUP INC	3bef5915-1c98-4011-baa9-ad0bbef200c2	2023-11-10	Warnings	Exact identifier application number: M015
BODY ACTION PRODUCTS Butt Eze Benzocaine	BENZOCAINE	PRODUCT MAX GROUP INC	ba75b129-7939-4373-91f5-1772976e6d61	2023-11-10	Warnings	Exact identifier application number: M015
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	441c802f-a363-1530-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M015
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	4939a547-c94b-3350-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M015
DR REAL NUMB Topical Anorectal	LIDOCAINE	FUZZYLULU LLC	378d8edc-2120-416d-854c-8881c2950efe	2023-11-09	Warnings	Exact identifier application number: M015
The Pharma C Company Medicated Foam with Witch Hazel	WITCH HAZEL	Kleen Test Products Corporation	1a1fbe83-be45-4654-a7bb-e934e1ccd0c6	2023-11-09	Warnings	Exact identifier application number: M015
The Pharma-C Company Medicated Hemorrhoidal Pads	WITCH HAZEL	Kleen Test Products Corporation	357703ab-4e7a-41f6-9ecf-aa98acc2d92e	2023-11-09	Warnings	Exact identifier application number: M015
DOCTORS TOUCH Erase The Pain Lidocaine	LIDOCAINE HYDROCHLORIDE	DOCTOR'S CHOICE MEDICAL, LLC	3dc9947b-8196-4a38-97b4-c2340ee77e0f	2023-11-06	Warnings	Exact identifier application number: M015
SCALAR Pain Relief Cream	MENTHOL	Miracle Balance, LLC	52a13cfe-3f46-45f8-a5af-ce07ea5758e3	2023-11-06	Warnings	Exact identifier application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief Cream	PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	SIMPLE PROMISE PTE LTD	f6622caa-3b31-9b07-e053-2a95a90a8a51	2023-11-06	Warnings	Exact identifier application number: M015
WAXUP Numbing	LIDOCAINE HYDROCHLORIDE	CONSTRUSOLUTION, LLC	4f1645ab-1b19-4d69-99c3-9ea275b01a87	2023-11-06	Warnings	Exact identifier application number: M015
SECONDARY NUMB Lidocaine Phenylephrine Gel	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	LALANI Rx Consulting, Inc.	0f13f7b5-e3b1-451e-a6d6-e7e15bd04443	2023-11-06	Warnings	Exact identifier application number: M015
Brazzers Anal Desensitizing	LIDOCAINE	Metro Media Ent	ceacd80c-0dd6-4e21-97da-56da877b1c90	2023-11-06	Warnings	Exact identifier application number: M015
NUMB PLUS Maximum Strength Anorectal	LIDOCAINE	SEENEXT VENTURE LTD	a7c37b2a-b647-43d7-b43b-87bbece35430	2023-11-05	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