Dentree

Product NDC: 76170-101
Requested package NDC: 76170-101-50
11-digit product format: 761700101
Labeler code: 76170
Product ID: 76170-101_a3be7b7e-f78d-168b-e053-2a95a90a4b15
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: 2012-04-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/1000mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76170-101	76170-101-50	I	Inactivated by FDA		2026-11-13

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 · 19 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76170-101-50	2022-01-28	C162847	48780-1	97449f38-d040-f6ea-e053-dbdaa90aa703	Drug Facts
76170-101-50	2020-04-20	C162847	48780-1	97449f38-d040-f6ea-e053-dbdaa90aa703	Drug Facts
76170-101-50	2019-11-13	C162847	48780-1	97449f38-d040-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76170-101-50	Dentree	50 mL in 1 BOTTLE, PUMP	GEL, DENTIFRICE	50		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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76170-101	DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]	2	Legacy NDC, 1 package rows	20200421_ede7caf8-0384-9d2b-83b8-a88c38a66a11.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	ede7caf8-0384-9d2b-83b8-a88c38a66a11	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	ede7caf8-0384-9d2b-83b8-a88c38a66a11	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	ede7caf8-0384-9d2b-83b8-a88c38a66a11	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76170-101-50	76170010150	50 mL in 1 BOTTLE, PUMP (76170-101-50)	50 ml	2012-04-01	0000-00-00	No	No	Current