Home NDC 64068-500-01 Endit zinc oxide skin protection
Product NDC 64068-500
Requested package NDC 64068-500-01
11-digit product format 640680500
Labeler code 64068
Product ID 64068-500_47f5517a-46c6-6d06-e063-6394a90aa5c9
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler EndIt Laboratories, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-09
Substance ZINC OXIDE
Active strength 200 mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Endit zinc oxide skin protection
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198911 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64068-500-01 Endit zinc oxide skin protection 56.7 g in 1 JAR OINTMENT 56.7 3 64068-500-02 Endit zinc oxide skin protection 113.4 g in 1 JAR OINTMENT 113.4 3 64068-500-03 Endit zinc oxide skin protection 227 g in 1 JAR OINTMENT 227 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64068-500 ENDIT ZINC OXIDE SKIN PROTECTION (ZINC OXIDE) OINTMENT [ENDIT LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20231215_e60bb0da-3349-f8f9-e053-2a95a90a9051.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 58 of 68 · 1,350 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64068-500-01 64068050001 56.7 g in 1 JAR (64068-500-01) 56.7 g 2022-08-09 0000-00-00 No No Current