Home NDC 58518-010 ENVIRONMENTAL DEFENSE
Product NDC 58518-010
11-digit product format 585180010
Labeler code 58518
Product ID 58518-010_49534937-860f-bf99-e063-6394a90a0e02
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Avasol LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-18
Substance ZINC OXIDE
Active strength 225 mg/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 58518-010 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58518-010 58518-010-01 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 ENVIRONMENTAL DEFENSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 225 mg/100mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58518-010-02 ENVIRONMENTAL DEFENSE 60 mL in 1 POUCH CREAM 60 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58518-010 ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241222_1fbddab4-71f7-4167-ad21-30040b7c71bb.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 26 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58518-010-01 58518001001 75 mL in 1 BOTTLE, PUMP (58518-010-01) 75 ml 2013-07-18 0000-00-00 No No Current 58518-010-02 58518001002 60 mL in 1 POUCH (58518-010-02) 60 ml 2021-11-29 0000-00-00 No No Current