Dynarex Zinc Oxide

Product NDC: 67777-119
11-digit product format: 677770119
Labeler code: 67777
Product ID: 67777-119_ee2777e6-235a-30bd-e053-2a95a90afae4
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide Ointment
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Dynarex Corporation
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-03-27
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 250 mg/g
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67777-119		D	Discontinued by firm	2026-10-16
excluded package	package	67777-119	67777-119-02	D	Discontinued by firm	2026-10-16
excluded package	package	67777-119	67777-119-12	D	Discontinued by firm	2026-10-16
excluded package	package	67777-119	67777-119-21	D	Discontinued by firm	2026-10-16

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 · 8 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	67777-119-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-119-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67777-119-12	`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	67777-119-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-119-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67777-119-12	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-119-10	GM - Gram	67777-119	ce5be7f6-daa5-4525-832c-e4f1ba8257e5	1	2023-02-06
67777-119-12	GM - Gram	67777-119	23991df9-14c7-420c-aada-0f0eb571cee4	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-119	DYNAREX ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]	7	Legacy NDC	20241122_686729af-f96e-a860-e053-2a91aa0af575.zip

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
67777-119-00	67777011900	28.4 g in 1 TUBE (67777-119-00)	28.4 g	2018-03-27	0000-00-00	No	No	Current
67777-119-02	67777011902	72 BOX in 1 CASE (67777-119-02) > 1 TUBE in 1 BOX (67777-119-01) > 28.4 g in 1 TUBE (67777-119-00)	72 box	2018-03-27	0000-00-00	No	No	Current
67777-119-10	67777011910	56.7 g in 1 TUBE (67777-119-10)	56.7 g	2018-03-27	0000-00-00	No	No	Current
67777-119-12	67777011912	72 BOX in 1 CASE (67777-119-12) > 1 TUBE in 1 BOX (67777-119-11) > 56.7 g in 1 TUBE (67777-119-10)	72 box	2018-03-27	0000-00-00	No	No	Current
67777-119-20	67777011920	425 g in 1 JAR (67777-119-20)	425 g	2018-03-27	0000-00-00	No	No	Current
67777-119-21	67777011921	12 JAR in 1 CASE (67777-119-21) > 425 g in 1 JAR (67777-119-20)	12 jar	2018-03-27	0000-00-00	No	No	Current