WL-ACA-Z-A-1444

Product NDC
63931-4507
Requested package NDC
63931-4507-1
11-digit product format
639314507
Labeler code
63931
Product ID
63931-4507_da5f0685-a4dd-1ec6-e053-2a95a90a1bd2
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
2022-03-16
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
107 mg/mL
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.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63931-4507-163931450701150000 mL in 1 DRUM (63931-4507-1) 150000 ml2022-03-160000-00-00NoNoCurrent