Dentree

Product NDC
76170-102
Requested package NDC
76170-102-02
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76170-10276170-102-02IInactivated by FDA2026-10-05

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 1 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…a55b01930146…

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
NDCEffectiveRelated label
76170-102-012022-01-28Drug Facts
76170-102-022022-01-28Drug Facts
76170-102-032022-01-28Drug Facts
76170-102-012020-04-20Drug Facts
76170-102-022020-04-20Drug Facts
76170-102-032020-04-20Drug Facts
76170-102-012019-11-27Drug Facts
76170-102-022019-11-27Drug Facts
76170-102-032019-11-27Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76170-102-01Dentree30 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE302
76170-102-01Dentree1 in 1 CARTONGEL, DENTIFRICE12
76170-102-02Dentree1 in 1 CARTONGEL, DENTIFRICE12
76170-102-02Dentree50 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE502
76170-102-03Dentree100 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE1002
76170-102-03Dentree1 in 1 CARTONGEL, DENTIFRICE12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76170-102DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]2Legacy NDC, 6 package rows20200421_b30f2f18-0966-1f6b-e2fd-32e49555aa28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSNb30f2f18-0966-1f6b-e2fd-32e49555aa282
245598sodium fluoride 0.0022 MG/MG ToothpasteSCDb30f2f18-0966-1f6b-e2fd-32e49555aa282
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSYb30f2f18-0966-1f6b-e2fd-32e49555aa282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76170-102-02761700102021 BOTTLE, PUMP in 1 CARTON (76170-102-02) > 50 mL in 1 BOTTLE, PUMP2012-12-010000-00-00NoNoCurrent