Dr. Whitiss (8.3%)

Product NDC: 47649-9001
11-digit product format: 476499001
Labeler code: 47649
Product ID: 47649-9001_5f0112bb-31bf-d5c1-e053-2a91aa0a44d5
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: 2014-07-11
Marketing end: 0000-00-00
Substance: CARBAMIDE PEROXIDE
Active strength: 0 g/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	47649-9001		I	Inactivated by FDA	2026-08-11
excluded package	package	47649-9001	47649-9001-1	I	Inactivated by FDA	2026-08-11
excluded package	package	47649-9001	47649-9001-3	I	Inactivated by FDA	2026-08-11

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 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47649-9001-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47649-9001-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47649-9001-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47649-9001-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47649-9001-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47649-9001-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47649-9001-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47649-9001-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47649-9001-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47649-9001-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47649-9001-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47649-9001-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47649-9001-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47649-9001-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47649-9001-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47649-9001-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47649-9001-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47649-9001-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47649-9001-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47649-9001-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47649-9001-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47649-9001-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47649-9001-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47649-9001-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	47649-9001-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	47649-9001-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	47649-9001-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	47649-9001-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	47649-9001-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	47649-9001-1	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47649-9001-1	2024-01-30	C162847	48780-1	1030e365-2da7-111a-e063-dadaa90a10e2	Drug Facts
47649-9001-3	2024-01-30	C162847	48780-1	1030e365-2da7-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47649-9001-1	Dr. Whitiss (8.3%)	5 g in 1 PACKAGE	GEL, DENTIFRICE	5	3
47649-9001-2	Dr. Whitiss (8.3%)	2 g in 1 CYLINDER	GEL, DENTIFRICE	2	3
47649-9001-3	Dr. Whitiss (8.3%)	4 in 1 PACKAGE	GEL, DENTIFRICE	4	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMIDE PEROXIDE	ACTIVE INGREDIENT	31PZ2VAU81	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1
HYDROGEN PEROXIDE	ACTIVE MOIETY	BBX060AN9V	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1
POTASSIUM NITRATE	INACTIVE INGREDIENT	RU45X2JN0Z	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1
water	INACTIVE INGREDIENT	059QF0KO0R	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47649-9001	DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]	3	Legacy NDC, 3 package rows	20171128_1f4d7ad3-433c-40b3-842e-73a327214d86.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31PZ2VAU81	CARBAMIDE PEROXIDE	124-43-6	CARBAMIDE PEROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47649-9001-1	47649900101	5 g in 1 PACKAGE (47649-9001-1)	5 g	2014-07-11	0000-00-00	No	No	Current
47649-9001-2	47649900102	2 g in 1 CYLINDER	2 g					Historical
47649-9001-3	47649900103	4 CYLINDER in 1 PACKAGE (47649-9001-3) > 2 g in 1 CYLINDER (47649-9001-2)	4 cylinder	2014-07-11	0000-00-00	No	No	Current