zinc oxide

Product NDC: 67777-226
11-digit product format: 677770226
Labeler code: 67777
Product ID: 67777-226_a137e963-1fa0-4772-a6a1-1d7a01bf1040
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Dynarex Corporation
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 2 g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67777-226		I	Inactivated by FDA	2026-10-12
excluded package	package	67777-226	67777-226-01	I	Inactivated by FDA	2026-10-12
excluded package	package	67777-226	67777-226-02	I	Inactivated by FDA	2026-10-12
excluded package	package	67777-226	67777-226-03	I	Inactivated by FDA	2026-10-12
excluded package	package	67777-226	67777-226-04	I	Inactivated by FDA	2026-10-12

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 · 105 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	67777-226-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-226-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-226-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-226-02	`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	67777-226-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-226-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-226-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-226-02	`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	67777-226-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-226-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-226-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67777-226-02	`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	67777-226-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-226-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-226-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67777-226-02	`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	67777-226-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-226-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-226-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67777-226-02	`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	67777-226-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-226-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-226-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67777-226-02	`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	67777-226-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-226-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-226-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67777-226-02	`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	67777-226-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-226-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-226-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67777-226-02	`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	67777-226-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-226-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-226-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67777-226-02	`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	67777-226-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-226-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-226-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67777-226-02	`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	67777-226-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-226-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-226-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67777-226-02	`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	67777-226-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-226-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-226-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67777-226-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67777-226-01	Zinc Oxide Ointment
67777-226-02	Zinc Oxide Ointment
67777-226-03	Zinc Oxide Ointment
67777-226-04	Zinc Oxide Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-226-01	zinc oxide	5 g in 1 PACKET	OINTMENT	5	12
67777-226-01	zinc oxide	144 in 1 BOX	OINTMENT	144	12
67777-226-02	zinc oxide	36 in 1 BOX	OINTMENT	36	12
67777-226-02	zinc oxide	15 g in 1 PACKET	OINTMENT	15	12
67777-226-03	zinc oxide	24 in 1 CASE	OINTMENT	24	12
67777-226-03	zinc oxide	114 g in 1 TUBE	OINTMENT	114	12
67777-226-04	zinc oxide	427.5 g in 1 JAR	OINTMENT	427.5	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-226-01	GM - Gram	67777-226	3354628d-e07a-4c7a-9679-4313ed13c5df	1	2022-06-06
67777-226-02	GM - Gram	67777-226	f7f44a28-d5b2-46fa-be33-0d9edb7765bc	1	2022-06-06
67777-226-03	GM - Gram	67777-226	0edeaf18-38ee-4090-b577-71e4057360c7	1	2022-06-06
67777-226-04	GM - Gram	67777-226	4177dc01-cc66-4513-8bbf-e0af03b155f9	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
CETETH-10	INACTIVE INGREDIENT	LF9X1PN3XJ	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-226	ZINC OXIDE OINTMENT [DYNAREX CORPORATION]	12	Legacy NDC, 7 package rows	20140522_049b727b-6abd-410c-a5d8-7b9c0fdfdbeb.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
1044412	zinc oxide 1.8 % Topical Ointment	PSN	049b727b-6abd-410c-a5d8-7b9c0fdfdbeb	12
1044412	zinc oxide 0.018 MG/MG Topical Ointment	SCD	049b727b-6abd-410c-a5d8-7b9c0fdfdbeb	12
1044412	zinc oxide 1.8 % Topical Ointment	SY	049b727b-6abd-410c-a5d8-7b9c0fdfdbeb	12
1044412	ZNO 0.018 MG/MG Topical Ointment	SY	049b727b-6abd-410c-a5d8-7b9c0fdfdbeb	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67777-226-01	67777022601	5 g in 1 PACKET	5 g	Historical
67777-226-02	67777022602	36 in 1 BOX		Historical
67777-226-03	67777022603	24 in 1 CASE		Historical
67777-226-04	67777022604	427.5 g in 1 JAR	427.5 g	Historical