Zinc Oxide

Product NDC
50382-051
Requested package NDC
50382-051-14
11-digit product format
503820051
Labeler code
50382
Product ID
50382-051_ee828336-d292-2eb6-e053-2995a90ad9db
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-04
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
NDCEffectiveActionDocumentIndexing SPLRelated label
50382-051-012019-11-27C16284748780-19855d018-d49c-cd31-e053-dbdaa90ab51aZinc Oxide Ointment
50382-051-022019-11-27C16284748780-19855d018-d49c-cd31-e053-dbdaa90ab51aZinc Oxide Ointment
50382-051-032019-11-27C16284748780-19855d018-d49c-cd31-e053-dbdaa90ab51aZinc Oxide Ointment

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-051ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]4Legacy NDC20130726_1deec882-5c29-44f8-8a74-4ec5bed2eadc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50382-051-14503820051141 TUBE in 1 CARTON (50382-051-14) > 56 g in 1 TUBE1 tube2013-04-040000-00-00NoNoCurrent