teeth desensitizing and remineralizing gel

Product NDC: 49410-200
11-digit product format: 494100200
Labeler code: 49410
Product ID: 49410-200_62180c5e-1369-1c60-e053-2a91aa0a3668
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium nitrate,Sodium Fluoride,Sodium Monofluorophosphate
Dosage form: PASTE
Route: DENTAL
Labeler: Fuzhou Difeng Bio-tech Co., Ltd.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-03-07
Marketing end: 0000-00-00
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50 mg/g; mg/g
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49410-200		I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-01	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-02	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-03	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-04	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-05	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-06	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-07	I	Inactivated by FDA	2026-10-05
excluded package	package	49410-200	49410-200-08	I	Inactivated by FDA	2026-10-05

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 4 · 189 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	49410-200-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49410-200-03	`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	49410-200-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49410-200-03	`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	49410-200-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49410-200-03	`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	49410-200-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49410-200-03	`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	49410-200-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49410-200-03	`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	49410-200-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49410-200-03	`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	49410-200-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49410-200-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49410-200-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49410-200-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49410-200-08	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
49410-200-01	teeth desensitizing and remineralizing gel 49410-200
49410-200-02	teeth desensitizing and remineralizing gel 49410-200
49410-200-03	teeth desensitizing and remineralizing gel 49410-200
49410-200-04	teeth desensitizing and remineralizing gel 49410-200
49410-200-05	teeth desensitizing and remineralizing gel 49410-200
49410-200-06	teeth desensitizing and remineralizing gel 49410-200
49410-200-07	teeth desensitizing and remineralizing gel 49410-200
49410-200-08	teeth desensitizing and remineralizing gel 49410-200

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49410-200-01	teeth desensitizing and remineralizing gel	200 in 1 CONTAINER	PASTE	200	3
49410-200-01	teeth desensitizing and remineralizing gel	5 in 1 CARTON	PASTE	5	3
49410-200-02	teeth desensitizing and remineralizing gel	100 in 1 CONTAINER	PASTE	100	3
49410-200-02	teeth desensitizing and remineralizing gel	5 in 1 CARTON	PASTE	5	3
49410-200-03	teeth desensitizing and remineralizing gel	100 in 1 CONTAINER	PASTE	100	3
49410-200-03	teeth desensitizing and remineralizing gel	5 in 1 CARTON	PASTE	5	3
49410-200-04	teeth desensitizing and remineralizing gel	80 in 1 CONTAINER	PASTE	80	3
49410-200-04	teeth desensitizing and remineralizing gel	5 in 1 CARTON	PASTE	5	3
49410-200-05	teeth desensitizing and remineralizing gel	6 in 1 CARTON	PASTE	6	3
49410-200-05	teeth desensitizing and remineralizing gel	300 in 1 CONTAINER	PASTE	300	3
49410-200-06	teeth desensitizing and remineralizing gel	200 in 1 CONTAINER	PASTE	200	3
49410-200-06	teeth desensitizing and remineralizing gel	6 in 1 CARTON	PASTE	6	3
49410-200-07	teeth desensitizing and remineralizing gel	6 in 1 CARTON	PASTE	6	3
49410-200-07	teeth desensitizing and remineralizing gel	333 in 1 CONTAINER	PASTE	333	3
49410-200-08	teeth desensitizing and remineralizing gel	300 in 1 CARTON	PASTE	300	3
49410-200-08	teeth desensitizing and remineralizing gel	3.5 g in 1 VIAL, SINGLE-USE	PASTE	3.5	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49410-200	TEETH DESENSITIZING AND REMINERALIZING GEL (POTASSIUM NITRATE,SODIUM FLUORIDE,SODIUM MONOFLUOROPHOSPHATE) PASTE [FUZHOU DIFENG BIO-TECH CO., LTD.]	3	Legacy NDC, 16 package rows	20180108_2d4e6542-faa9-63f2-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038841	potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste	PSN	2d4e6542-faa9-63f2-e054-00144ff8d46c	3
1038841	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG Toothpaste	SCD	2d4e6542-faa9-63f2-e054-00144ff8d46c	3
1038841	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste	SY	2d4e6542-faa9-63f2-e054-00144ff8d46c	3
1038841	pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel Toothpaste	SY	2d4e6542-faa9-63f2-e054-00144ff8d46c	3
1038841	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG Toothpaste	SY	2d4e6542-faa9-63f2-e054-00144ff8d46c	3
1038841	potassium nitrate 5 % / sodium fluoride 0.15 % Toothpaste	SY	2d4e6542-faa9-63f2-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
49410-200-01	49410020001	200 in 1 CONTAINER	Historical
49410-200-02	49410020002	100 in 1 CONTAINER	Historical
49410-200-03	49410020003	100 in 1 CONTAINER	Historical
49410-200-04	49410020004	80 in 1 CONTAINER	Historical
49410-200-05	49410020005	6 in 1 CARTON	Historical
49410-200-06	49410020006	200 in 1 CONTAINER	Historical
49410-200-07	49410020007	6 in 1 CARTON	Historical
49410-200-08	49410020008	300 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
teeth desensitizing and remineralizing gel 49410-200	Fuzhou Difeng Bio-tech Co., Ltd.	2018-01-06	HUMAN OTC DRUG LABEL	3