FDA.reportPublic FDA data

AMERFRESH FLUORIDE gel

Product NDC
70766-008
Requested package NDC
70766-008-03
11-digit product format
707660008
Labeler code
70766
Product ID
70766-008_d921cab5-a798-63b9-e053-2995a90a9df8
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
2022-02-28
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 packagepackage70766-00870766-008-03IInactivated by FDA2026-10-05

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
70766-008-0170766-008
70766-008-0270766-008
70766-008-0370766-008
70766-008-0470766-008
70766-008-0570766-008
70766-008-0670766-008
70766-008-0770766-008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-008-01AMERFRESH FLUORIDE gel17 g in 1 TUBEPASTE, DENTIFRICE173
70766-008-01AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-02AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-02AMERFRESH FLUORIDE gel24 g in 1 TUBEPASTE, DENTIFRICE243
70766-008-03AMERFRESH FLUORIDE gel43 g in 1 TUBEPASTE, DENTIFRICE433
70766-008-03AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-04AMERFRESH FLUORIDE gel78 g in 1 TUBEPASTE, DENTIFRICE783
70766-008-04AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-05AMERFRESH FLUORIDE gel85 g in 1 TUBEPASTE, DENTIFRICE853
70766-008-05AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-06AMERFRESH FLUORIDE gel142 g in 1 TUBEPASTE, DENTIFRICE1423
70766-008-06AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-07AMERFRESH FLUORIDE gel1000 in 1 BOXPASTE, DENTIFRICE10003
70766-008-07AMERFRESH FLUORIDE gel7 g in 1 POUCHPASTE, DENTIFRICE73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-008AMERFRESH FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]3Legacy NDC, 14 package rows20241218_11c712ee-638f-4539-b73a-2f997f433ed4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN11c712ee-638f-4539-b73a-2f997f433ed43
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD11c712ee-638f-4539-b73a-2f997f433ed43
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY11c712ee-638f-4539-b73a-2f997f433ed43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-008-0370766000803144 TUBE in 1 BOX (70766-008-03) > 43 g in 1 TUBE144 tube2022-02-280000-00-00NoNoCurrent