Dentree

Product NDC: 76170-102
11-digit product format: 761700102
Labeler code: 76170
Product ID: 76170-102_a3be8bbd-6419-2574-e053-2a95a90a3f6c
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: E-SOUP Co., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-12-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76170-102		I	Inactivated by FDA	2026-10-05
excluded package	package	76170-102	76170-102-01	I	Inactivated by FDA	2026-10-05
excluded package	package	76170-102	76170-102-02	I	Inactivated by FDA	2026-10-05
excluded package	package	76170-102	76170-102-03	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 2 · 76 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	76170-102-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76170-102-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76170-102-01	`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	76170-102-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76170-102-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76170-102-01	`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	76170-102-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76170-102-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76170-102-01	`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	76170-102-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76170-102-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76170-102-01	`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	76170-102-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76170-102-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76170-102-01	`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	76170-102-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76170-102-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76170-102-01	`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	76170-102-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76170-102-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76170-102-01	`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	76170-102-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76170-102-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76170-102-01	`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	76170-102-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76170-102-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76170-102-01	`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	76170-102-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76170-102-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76170-102-01	`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	76170-102-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76170-102-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76170-102-01	`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	76170-102-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76170-102-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76170-102-01	`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	76170-102-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76170-102-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76170-102-01	`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	76170-102-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76170-102-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76170-102-01	`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	76170-102-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76170-102-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76170-102-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76170-102-01	2022-01-28	Drug Facts
76170-102-02	2022-01-28	Drug Facts
76170-102-03	2022-01-28	Drug Facts
76170-102-01	2020-04-20	Drug Facts
76170-102-02	2020-04-20	Drug Facts
76170-102-03	2020-04-20	Drug Facts
76170-102-01	2019-11-27	Drug Facts
76170-102-02	2019-11-27	Drug Facts
76170-102-03	2019-11-27	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76170-102-01	Dentree	30 mL in 1 BOTTLE, PUMP	GEL, DENTIFRICE	30	2
76170-102-01	Dentree	1 in 1 CARTON	GEL, DENTIFRICE	1	2
76170-102-02	Dentree	1 in 1 CARTON	GEL, DENTIFRICE	1	2
76170-102-02	Dentree	50 mL in 1 BOTTLE, PUMP	GEL, DENTIFRICE	50	2
76170-102-03	Dentree	100 mL in 1 BOTTLE, PUMP	GEL, DENTIFRICE	100	2
76170-102-03	Dentree	1 in 1 CARTON	GEL, DENTIFRICE	1	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Allantoin	INACTIVE INGREDIENT	344S277G0Z	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Artemisia Princeps Leaf	INACTIVE INGREDIENT	SY077EW02G	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Ginger	INACTIVE INGREDIENT	C5529G5JPQ	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Ligusticum Wallichii Whole	INACTIVE INGREDIENT	8Y1N3NX2DW	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Tribasic Calcium Phosphate	INACTIVE INGREDIENT	91D9GV0Z28	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76170-102	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	2	Legacy NDC, 6 package rows	20200421_b30f2f18-0966-1f6b-e2fd-32e49555aa28.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	b30f2f18-0966-1f6b-e2fd-32e49555aa28	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	b30f2f18-0966-1f6b-e2fd-32e49555aa28	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	b30f2f18-0966-1f6b-e2fd-32e49555aa28	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76170-102-01	76170010201	1 BOTTLE, PUMP in 1 CARTON (76170-102-01) > 30 mL in 1 BOTTLE, PUMP	2012-12-01	0000-00-00	No	No	Current
76170-102-02	76170010202	1 BOTTLE, PUMP in 1 CARTON (76170-102-02) > 50 mL in 1 BOTTLE, PUMP	2012-12-01	0000-00-00	No	No	Current
76170-102-03	76170010203	1 BOTTLE, PUMP in 1 CARTON (76170-102-03) > 100 mL in 1 BOTTLE, PUMP	2012-12-01	0000-00-00	No	No	Current