WL-AAJ-Z-W-818

Product NDC
63931-4416
Requested package NDC
63931-4416-1
11-digit product format
639314416
Labeler code
63931
Product ID
63931-4416_cc31bea3-76ce-00e4-e053-2995a90ad4e4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Nanophase Technologies Corporation
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-10
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
132 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63931-4416-163931441601160000000 mL in 1 DRUM (63931-4416-1) 160000000 ml2021-06-100000-00-00NoNoCurrent