FDA.reportPublic FDA data

Dynarex Zinc Oxide

Product NDC
67777-119
Requested package NDC
67777-119-12
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67777-11967777-119-12DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67777-11967777-119-12DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67777-11967777-119-12DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-119-10GM - Gram67777-119ce5be7f6-daa5-4525-832c-e4f1ba8257e512023-02-06
67777-119-12GM - Gram67777-11923991df9-14c7-420c-aada-0f0eb571cee412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-119DYNAREX ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]7Legacy NDC20241122_686729af-f96e-a860-e053-2a91aa0af575.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-119-126777701191272 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 box2018-03-270000-00-00NoNoCurrent