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 47 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box Set	BIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.	Guangdong Junhui Biotechnology Co., LTD	22736b2d-45a0-49b6-e063-6394a90a7b0b	2025-01-08	Warnings	Exact identifier application number: M016
Body Milk for stretch marks	HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTER	Guangzhou Senmai Biotechnology Co.	1dcd94dc-214d-de72-e063-6294a90a695f	2025-01-08	Warnings	Exact identifier application number: M016
Stretch Marks cream	SESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.	Guangzhou Senmai Biotechnology Co.	1e827483-259a-d12f-e063-6394a90a7885	2025-01-08	Warnings	Exact identifier application number: M016
Body oil for stretch marks	HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0IL	Guangzhou Senmai Biotechnology Co.	1daeb2e8-f18c-06c3-e063-6294a90a6385	2025-01-08	Warnings	Exact identifier application number: M016
AOA0 Snail Ginseng Cream	SNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.	Guangdong Junhui Biotechnology Co., LTD	22873a99-1032-f4ec-e063-6394a90a6432	2025-01-08	Warnings	Exact identifier application number: M016
Massage cream for stretch marks	HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL	Guangzhou Senmai Biotechnology Co.	1dce7cf1-1fb8-e14e-e063-6394a90ae34a	2025-01-08	Warnings	Exact identifier application number: M016
AOAO Retinol Anti-aging Box Set	COLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.	Guangdong Junhui Biotechnology Co., LTD	24fdc31b-5291-a649-e063-6394a90a9c65	2025-01-08	Warnings	Exact identifier application number: M016
Sulfur anti-mite shower gel	SODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.	Guangdong Junhui Biotechnology Co., Ltd	251ee057-1adf-bc97-e063-6394a90acdd3	2025-01-08	Warnings	Exact identifier application number: M016
TURMERICFaceCream	NIACINAMIDE	Shengnan (Guangzhou) Cosmetics Co., LTD	2b0652be-a216-d66b-e063-6394a90a0b28	2025-01-06	Warnings	Exact identifier application number: M016
Menthol and Zinc Oxide	MENTHOL AND ZINC OXIDE	GERI-GENTLE CORPORATION	e673d8bd-2573-9f04-e053-2995a90a172a	2025-01-06	Warnings	Exact identifier application number: M016
ClearSoothingCream	HYALURONIC ACID	Shengnan (Guangzhou) Cosmetics Co., LTD	2ac88f9a-a41b-1978-e063-6394a90a2421	2025-01-03	Warnings	Exact identifier application number: M016
MILKBODyLotion	UREA	Shengnan (Guangzhou) Cosmetics Co., LTD	2ac99028-a811-9332-e063-6294a90aee5c	2025-01-03	Warnings	Exact identifier application number: M016
Royal Jelly Scar Balm	DIMETHICONE	Distribuidora Comercial Jafra, S.A. de C.V.	27be84c1-0227-41ca-beb6-3855eff77e41	2025-01-02	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1ea9640-4a6d-1c76-e053-2a95a90ad3b1	2024-12-31	Warnings	Exact identifier application number: M016
Badger Diaper	ZINC OXIDE	W.S. Badger Company, Inc.	674542b2-33fb-4664-857d-4ff1d7f768a0	2024-12-31	Warnings	Exact identifier application number: M016
A and D Diaper Rash and Skin Protectant	LANOLIN AND PETROLATUM	Natureplex LLC	fcaf27c9-3634-4fb7-a311-2e093f055278	2024-12-31	Warnings	Exact identifier application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR	LIP PROTECTANT	REVLON CONSUMER PRODUCTS CORP	f3a6fe29-7af7-bfb1-e053-2a95a90a0101	2024-12-30	Warnings	Exact identifier application number: M016
SkinCeuticals Advanced Scar Control Skin Protectant	ALLANTOIN	L'Oreal USA Products Inc	83f4bfbb-47d8-4fe9-ba33-85142ec6221c	2024-12-28	Warnings	Exact identifier application number: M016
Personal Cleansing with Dimethicone	DIMETHICONE	Cardinal Health 200, Inc	3f9a1a90-ab12-4911-b8c2-df200b0dde5b	2024-12-27	Warnings	Exact identifier application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDE	ZINC OXIDE	Bentley Laboratories, LLC	a35ae585-f899-4c7e-8cd2-c0b2fe6a2078	2024-12-27	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