FDA.reportPublic FDA data

Amerfresh Tooth

Product NDC
70766-004
Requested package NDC
70766-004-01
11-digit product format
707660004
Labeler code
70766
Product ID
70766-004_d332a465-aaad-f5c2-e053-2a95a90a34d2
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
POWDER
Route
DENTAL
Labeler
Yangzhou SION Commodity Co.,Ltd
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-04-20
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage70766-00470766-004-01IInactivated by FDA2026-10-15

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
70766-004-012026-01-29Amerfresh Fluoride Toothpaste
70766-004-022026-01-29Amerfresh Fluoride Toothpaste
70766-004-012023-03-15Amerfresh Fluoride Toothpaste
70766-004-022023-03-15Amerfresh Fluoride Toothpaste
70766-004-012023-01-30Amerfresh Fluoride Toothpaste
70766-004-022023-01-30Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-004-01Amerfresh Tooth454 g in 1 PACKAGEPOWDER4547
70766-004-01Amerfresh Tooth40 in 1 CARTONPOWDER407
70766-004-02Amerfresh Tooth50 in 1 BOXPOWDER507
70766-004-02Amerfresh Tooth4 in 1 CARTONPOWDER47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-004AMERFRESH TOOTH (SODIUM FLUORIDE) POWDER [YANGZHOU SION COMMODITY CO.,LTD]7Legacy NDC, 4 package rows20241218_ff4d62a9-2f0b-495f-aa52-9030193d7148.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-004-017076600040140 PACKAGE in 1 CARTON (70766-004-01) > 454 g in 1 PACKAGE40 package2018-04-200000-00-00NoNoCurrent