Home NDC 47649-1301-2 Dr.Whitiss 35%
Product NDC 47649-1301
Requested package NDC 47649-1301-2
11-digit product format 476491301
Labeler code 47649
Product ID 47649-1301_7dfa691f-3a41-82c1-e053-2a91aa0a3be8
Type HUMAN OTC DRUG
Nonproprietary name CARBAMIDE PEROXIDE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Nibec Co., Ltd
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-08-11
Marketing end 0000-00-00
Substance CARBAMIDE PEROXIDE
Active strength 35 g/100g
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 47649-1301-1 Dr.Whitiss 35% 1 g in 1 SYRINGE GEL, DENTIFRICE 1 4 47649-1301-2 Dr.Whitiss 35% 4 in 1 PACKAGE GEL, DENTIFRICE 4 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMIDE PEROXIDE ACTIVE INGREDIENT 31PZ2VAU81 DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3 HYDROGEN PEROXIDE ACTIVE MOIETY BBX060AN9V DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3 POTASSIUM NITRATE INACTIVE INGREDIENT RU45X2JN0Z DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3 water INACTIVE INGREDIENT 059QF0KO0R DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47649-1301 DR.WHITISS 35% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD] 4 Legacy NDC, 2 package rows 20181227_9ccab937-213d-45a2-8bf7-2aa9666fc1d9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47649-1301-2 47649130102 4 SYRINGE in 1 PACKAGE (47649-1301-2) > 1 g in 1 SYRINGE (47649-1301-1) 4 syringe 2015-08-11 0000-00-00 No No Current