Barrier Cream

Product NDC: 58518-040
11-digit product format: 585180040
Labeler code: 58518
Product ID: 58518-040_fbc1e407-09f5-1d83-e053-6294a90aef0f
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Avasol LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-01
Substance: ZINC OXIDE
Active strength: 100 mg/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 1 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58518-040-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58518-040-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58518-040-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58518-040-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58518-040-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58518-040-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58518-040-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58518-040-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58518-040-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58518-040-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58518-040-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58518-040-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58518-040-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58518-040-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58518-040-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58518-040-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58518-040-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58518-040-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	100 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
bc6a2736-faa6-46d3-af9b-a70f0762e9ce	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58518-040-02	2026-01-27	Barrier Cream
58518-040-03	2026-01-27	Barrier Cream
58518-040-02	2025-01-30	Barrier Cream
58518-040-03	2025-01-30	Barrier Cream
58518-040-02	2023-04-24	Barrier Cream
58518-040-03	2023-04-24	Barrier Cream
58518-040-02	2023-01-30	Barrier Cream
58518-040-03	2023-01-30	Barrier Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58518-040-02	Barrier Cream	59 mL in 1 POUCH	CREAM	59		3
58518-040-03	Barrier Cream	28 mL in 1 TUBE	CREAM	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58518-040	BARRIER CREAM (ZINC OXIDE) CREAM [AVASOL LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230425_bc6a2736-faa6-46d3-af9b-a70f0762e9ce.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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Skin Protectant	WHITE PETROLATUM	Your Military Exchanges	1a0aed14-8606-4676-b4b5-23dd415d43ac	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M016
Aloetouch Protect Fragrance Free	DIMETHICONE	Medline Industries, LP	81f0071b-2bf3-455b-9e5d-8f3ca20adcdf	2026-09-01	Warnings	Exact identifier application number: M016
PURE PETROLATUM	PETROLATUM	VASA COSMETICS PRIVATE LIMITED	5a57b197-3e18-b3ab-e063-6394a90aed82	2026-08-31	Warnings	Exact identifier application number: M016
HYDROPHOR	HYDROPHOR	Akron Pharma Inc.	e6099df7-d418-479a-9d2e-ced523585aed	2026-08-28	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	United Natural Foods, Inc. dba UNFI	d2d1bd9e-7025-4151-95f2-a2f521dc2be8	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Your Military Exchanges	e7af5488-1c49-41e9-9d8b-d519c6107699	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Your Military Exchanges	af95a66c-f063-4019-80c6-6f7dc4fee4d8	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M016
Estriol Cream	ESTRIOL	Guangxi Keyun E-commerce Co., Ltd.	4deadcb6-0d46-bdd7-e063-6294a90a26d7	2026-08-27	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	0d964138-f68d-dbf5-e063-6294a90a8320	2026-08-27	Warnings	Exact identifier application number: M016
Gembooxt ECZEMA RELIEF Cream	HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	46490d65-f789-eaa2-e063-6294a90a623b	2026-08-27	Warnings	Exact identifier application number: M016
Serawise Eczema Relief	OATMEAL	DrAnaMaria. Com LLC	f0681436-d140-4e02-afe4-5b16de07afcd	2026-08-26	Warnings	Exact identifier application number: M016
Hair Regrowth Foam	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	59ef5953-e96f-5707-e063-6294a90a3094	2026-08-26	Warnings	Exact identifier application number: M016
Growth Treatment	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	59fe12eb-574f-a199-e063-6394a90abd06	2026-08-26	Warnings	Exact identifier application number: M016
Acne Relief	SALICYLIC ACID,NIACINAMIDE,PANTHENOL.	Guangzhou Senmai Biotechnology Co.,Ltd.	59db0143-de57-59d2-e063-6294a90a32a8	2026-08-25	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Your Military Exchanges	4079fd56-55f3-4e69-93e0-7590c07fb794	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M016
Salicylic Acid Acne Gel Cleanser	SALICYLIC ACID,PANTHENOL	Guangzhou Senmai Biotechnology Co.,Ltd.	59eb395b-493b-efc9-e063-6294a90aa891	2026-08-25	Warnings	Exact identifier application number: M016
Claravie	DIMETHICONE	Gentell LLC	59c6da39-b5f1-8253-e063-6394a90a0e8f	2026-08-24	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	0d94fd18-a120-e171-e063-6394a90ae9c0	2026-08-24	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	59cf1d1e-e951-9d58-e063-6394a90af0f3	2026-08-24	Warnings	Exact identifier application number: M016
Claravie	ZINC OXIDE, DIMETHICONE	Gentell LLC	598a5c0b-1e2f-1335-e063-6394a90ac4f4	2026-08-21	Warnings	Exact identifier application number: M016

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
58518-040-02	58518004002	59 mL in 1 POUCH (58518-040-02)	59 ml	2022-01-01	0000-00-00	No	No	Current
58518-040-03	58518004003	28 mL in 1 TUBE (58518-040-03)	28 ml	2022-01-01	0000-00-00	No	No	Current