Novana Protect Barrier

Product NDC: 76077-300
11-digit product format: 760770300
Labeler code: 76077
Product ID: 76077-300_7dfb8b9c-ad7a-4ba9-bbc9-3e356fd002ae
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: NOVANA MEDICAL LLC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-04
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 0 mL/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76077-300		I	Inactivated by FDA	2026-10-05
excluded package	package	76077-300	76077-300-04	I	Inactivated by FDA	2026-10-05
excluded package	package	76077-300	76077-300-07	I	Inactivated by FDA	2026-10-05

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 · 66 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76077-300-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76077-300-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76077-300-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76077-300-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	76077-300-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76077-300-04	`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	76077-300-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76077-300-04	`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	76077-300-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76077-300-04	`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	76077-300-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76077-300-04	`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	76077-300-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76077-300-04	`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	76077-300-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76077-300-04	`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	76077-300-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76077-300-04	`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	76077-300-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76077-300-04	`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	76077-300-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76077-300-04	`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	76077-300-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76077-300-04	`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	76077-300-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76077-300-04	`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	76077-300-07	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76077-300-04	`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	76077-300-07	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76077-300-04	`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	76077-300-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76077-300-04	`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	76077-300-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76077-300-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76077-300-07	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76077-300-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76077-300-07	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76077-300-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76077-300-07	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76077-300-04	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76077-300-04	2019-11-13	C162847	48780-1	97449f38-cb78-f6ea-e053-dbdaa90aa703	Drug Facts
76077-300-07	2019-11-13	C162847	48780-1	97449f38-cb78-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76077-300-04	Novana Protect Barrier	120 mL in 1 TUBE	CREAM	120		3
76077-300-07	Novana Protect Barrier	210 mL in 1 TUBE	CREAM	210		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76077-300-04	GM - Gram	76077-300	c49b1c8e-aa4b-4281-91bb-e84c4c2014ac	1	2013-02-13
76077-300-07	GM - Gram	76077-300	359a6b66-885b-4414-a6ba-dcf503317a99	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Cod Liver Oil	INACTIVE INGREDIENT	BBL281NWFG	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Propanediol	INACTIVE INGREDIENT	5965N8W85T	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76077-300	NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]	3	Legacy NDC, 2 package rows	20120426_c857326a-655c-428d-ab96-a2da492194e6.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
417994	zinc oxide 12 % Topical Cream	PSN	c857326a-655c-428d-ab96-a2da492194e6	3
417994	zinc oxide 120 MG/ML Topical Cream	SCD	c857326a-655c-428d-ab96-a2da492194e6	3
417994	zinc oxide 12 % Topical Cream	SY	c857326a-655c-428d-ab96-a2da492194e6	3
417994	ZNO 120 MG/ML Topical Cream	SY	c857326a-655c-428d-ab96-a2da492194e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76077-300-04	76077030004	120 mL in 1 TUBE	120 ml	Historical
76077-300-07	76077030007	210 mL in 1 TUBE	210 ml	Historical