FDA.reportPublic FDA data

Oral Fusion Anticavity

Product NDC
70766-010
Requested package NDC
70766-010-01
11-digit product format
707660010
Labeler code
70766
Product ID
70766-010_ddbbb861-bbfb-4ed7-e053-2a95a90a079c
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Yangzhou SION Commodity Co.,Ltd
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-04-28
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage70766-01070766-010-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-010-01Oral Fusion Anticavity24 g in 1 TUBEPASTE, DENTIFRICE242
70766-010-01Oral Fusion Anticavity12 in 1 PACKAGEPASTE, DENTIFRICE122
70766-010-02Oral Fusion Anticavity24 g in 1 TUBEPASTE, DENTIFRICE242
70766-010-02Oral Fusion Anticavity48 in 1 CARTONPASTE, DENTIFRICE482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-010ORAL FUSION ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]2Legacy NDC, 4 package rows20231208_ddbbadff-9eb7-4a28-e053-2a95a90a168f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNddbbadff-9eb7-4a28-e053-2a95a90a168f2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDddbbadff-9eb7-4a28-e053-2a95a90a168f2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYddbbadff-9eb7-4a28-e053-2a95a90a168f2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYddbbadff-9eb7-4a28-e053-2a95a90a168f2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYddbbadff-9eb7-4a28-e053-2a95a90a168f2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYddbbadff-9eb7-4a28-e053-2a95a90a168f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-010-017076600100112 TUBE in 1 PACKAGE (70766-010-01) > 24 g in 1 TUBE12 tube2022-04-280000-00-00NoNoCurrent