FDA.reportPublic FDA data

Mint Fluoride Tooth

Product NDC
70766-011
Requested package NDC
70766-011-06
11-digit product format
707660011
Labeler code
70766
Product ID
70766-011_ef734cc7-34f9-0e37-e053-2a95a90aeb69
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Yangzhou SION Commodity Co.,Ltd
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-11-13
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 packagepackage70766-01170766-011-06IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-011-02Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-02Mint Fluoride Tooth12 in 1 BOXPASTE, DENTIFRICE123
70766-011-03Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-03Mint Fluoride Tooth24 in 1 BOXPASTE, DENTIFRICE243
70766-011-04Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-04Mint Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1443
70766-011-05Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-05Mint Fluoride Tooth288 in 1 BOXPASTE, DENTIFRICE2883
70766-011-06Mint Fluoride Tooth24 g in 1 TUBEPASTE, DENTIFRICE243
70766-011-06Mint Fluoride Tooth576 in 1 BOXPASTE, DENTIFRICE5763
70766-011-07Mint Fluoride Tooth12 in 1 POUCHPASTE, DENTIFRICE123
70766-011-07Mint Fluoride Tooth4 in 1 BOXPASTE, DENTIFRICE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-011MINT FLUORIDE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]3Legacy NDC, 12 package rows20231208_1fa163f3-6309-4bb3-85b8-6991d2eb758b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN1fa163f3-6309-4bb3-85b8-6991d2eb758b3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1fa163f3-6309-4bb3-85b8-6991d2eb758b3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1fa163f3-6309-4bb3-85b8-6991d2eb758b3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1fa163f3-6309-4bb3-85b8-6991d2eb758b3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1fa163f3-6309-4bb3-85b8-6991d2eb758b3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1fa163f3-6309-4bb3-85b8-6991d2eb758b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-011-0670766001106576 TUBE in 1 BOX (70766-011-06) > 24 g in 1 TUBE576 tube2022-12-100000-00-00NoNoCurrent