Home NDC 68400-489-11 Alcohol Antiseptic 70% Topical Solution
Product NDC 68400-489
Requested package NDC 68400-489-11
11-digit product format 684000489
Labeler code 68400
Product ID 68400-489_29a5751d-d005-5ab0-e063-6294a90a896a
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-01
Marketing end 2027-02-19
Substance ALCOHOL
Active strength 70 L/100L
NDC exclude flag No
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 Alcohol Antiseptic 70% Topical Solution Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 L/100L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M 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 68400-489-11 Alcohol Antiseptic 70% Topical Solution 1109 L in 1 BOTTLE, PLASTIC GEL 1109 3 68400-489-55 Alcohol Antiseptic 70% Topical Solution 208 L in 1 BOTTLE, PLASTIC GEL 208 2 68400-489-99 Alcohol Antiseptic 70% Topical Solution 995 L in 1 BOTTLE, PLASTIC GEL 995 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-489 ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 3 Current NDC, Legacy NDC, 1 package rows 20241222_aa95e99f-5c17-c394-e053-2995a90a6bf9.zip 68400-489 ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2 Current NDC, Legacy NDC, 1 package rows 20220126_aa81dc3d-d2f5-2f52-e053-2995a90a6e53.zip 68400-489 ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION (ALCOHOL) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2 Current NDC, Legacy NDC, 1 package rows 20220126_aa95903e-9679-35be-e053-2a95a90aacb8.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 1 of 1 · 1 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 68400-489-11 68400048911 1109 L in 1 BOTTLE, PLASTIC (68400-489-11) 1109 l 2020-06-01 2027-02-19 No No Current