Home NDC 60319-1001 Premium Whitening
Product NDC 60319-1001
11-digit product format 603191001
Labeler code 60319
Product ID 60319-1001_98daa928-8680-4e7a-e053-2a95a90ad104
Type HUMAN OTC DRUG
Nonproprietary name HYDROGEN PEROXIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Hankuk Bowonbio Co., Ltd
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-09-13
Marketing end 0000-00-00
Substance HYDROGEN PEROXIDE
Active strength 35 mL/100mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60319-1001-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60319-1001-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60319-1001-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60319-1001-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60319-1001-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60319-1001-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60319-1001-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60319-1001-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60319-1001-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60319-1001-1 Premium Whitening 4.3 mL in 1 BOTTLE, PLASTIC GEL, DENTIFRICE 4.3 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROGEN PEROXIDE ACTIVE INGREDIENT BBX060AN9V PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1 HYDROGEN PEROXIDE ACTIVE MOIETY BBX060AN9V PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1 SODIUM STANNATE INACTIVE INGREDIENT NJ7C1V83KG PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60319-1001 PREMIUM WHITENING (HYDROGEN PEROXIDE) GEL, DENTIFRICE [HANKUK BOWONBIO CO., LTD] 2 Legacy NDC, 1 package rows 20191204_77d048e9-6f92-486b-b65b-b5a8e5ac3a35.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60319-1001-1 60319100101 4.3 mL in 1 BOTTLE, PLASTIC (60319-1001-1) 4.3 ml 2016-12-01 0000-00-00 No No Current