Toothette Oral Care Single Use System with Antiseptic Oral Rinse

Product NDC: 53462-120
11-digit product format: 534620120
Labeler code: 53462
Product ID: 53462-120_816c614e-b914-ce70-3823-e8469e45dbd7
Type: HUMAN OTC DRUG
Nonproprietary name: HYDROGEN PEROXIDE
Dosage form: KIT
Labeler: Sage Products LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-31
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53462-120		I	Inactivated by FDA		2026-08-03
excluded package	package	53462-120	53462-120-60	I	Inactivated by FDA		2026-08-03

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 · 42 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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`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	53462-120-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53462-120-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53462-120-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53462-120-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53462-120-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53462-120-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53462-120-60	`9bebd1f3094a…`	`5416666fcb17…`

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
53462-120-60	2020-01-31	C162847	48780-1	9d75b9d0-234a-f424-e053-dadaa90a57ce	Toothette Oral Care Single Use System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53462-120-60	Toothette Oral Care Single Use System with Antiseptic Oral Rinse	1 in 1 KIT	KIT	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETYLPYRIDINIUM CHLORIDE	ACTIVE INGREDIENT	D9OM4SK49P	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
CETYLPYRIDINIUM	ACTIVE MOIETY	CUB7JI0JV3	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53462-120	TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]	1	Legacy NDC, 1 package rows	20140530_816c614e-b914-ce70-3823-e8469e45dbd7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	816c614e-b914-ce70-3823-e8469e45dbd7	1
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	816c614e-b914-ce70-3823-e8469e45dbd7	1
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	816c614e-b914-ce70-3823-e8469e45dbd7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53462-120-60	53462012060	1 in 1 KIT	Historical