FDA.reportPublic FDA data

Amerfresh

Product NDC
70766-003
11-digit product format
707660003
Labeler code
70766
Product ID
70766-003_d332a469-d257-e8a3-e053-2995a90a42e0
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
TOPICAL
Labeler
Yangzhou SION Commodity Co.,Ltd
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-03-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
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 · 14 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70766-003IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-01IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-02IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-03IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-04IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-05IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-06IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-07IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-08IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-09IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-10IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-11IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-12IInactivated by FDA2026-10-05
excluded packagepackage70766-00370766-003-13IInactivated by FDA2026-10-05

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
70766-003-012026-01-29Amerfresh Fluoride Toothpaste
70766-003-022026-01-29Amerfresh Fluoride Toothpaste
70766-003-032026-01-29Amerfresh Fluoride Toothpaste
70766-003-042026-01-29Amerfresh Fluoride Toothpaste
70766-003-052026-01-29Amerfresh Fluoride Toothpaste
70766-003-062026-01-29Amerfresh Fluoride Toothpaste
70766-003-072026-01-29Amerfresh Fluoride Toothpaste
70766-003-082026-01-29Amerfresh Fluoride Toothpaste
70766-003-092026-01-29Amerfresh Fluoride Toothpaste
70766-003-102026-01-29Amerfresh Fluoride Toothpaste
70766-003-112026-01-29Amerfresh Fluoride Toothpaste
70766-003-122026-01-29Amerfresh Fluoride Toothpaste
70766-003-132026-01-29Amerfresh Fluoride Toothpaste
70766-003-012023-12-08Amerfresh Fluoride Toothpaste
70766-003-022023-12-08Amerfresh Fluoride Toothpaste
70766-003-032023-12-08Amerfresh Fluoride Toothpaste
70766-003-042023-12-08Amerfresh Fluoride Toothpaste
70766-003-052023-12-08Amerfresh Fluoride Toothpaste
70766-003-062023-12-08Amerfresh Fluoride Toothpaste
70766-003-072023-12-08Amerfresh Fluoride Toothpaste
70766-003-082023-12-08Amerfresh Fluoride Toothpaste
70766-003-092023-12-08Amerfresh Fluoride Toothpaste
70766-003-102023-12-08Amerfresh Fluoride Toothpaste
70766-003-112023-12-08Amerfresh Fluoride Toothpaste
70766-003-122023-12-08Amerfresh Fluoride Toothpaste
70766-003-132023-12-08Amerfresh Fluoride Toothpaste
70766-003-012023-01-30Amerfresh Fluoride Toothpaste
70766-003-022023-01-30Amerfresh Fluoride Toothpaste
70766-003-032023-01-30Amerfresh Fluoride Toothpaste
70766-003-042023-01-30Amerfresh Fluoride Toothpaste
70766-003-052023-01-30Amerfresh Fluoride Toothpaste
70766-003-062023-01-30Amerfresh Fluoride Toothpaste
70766-003-072023-01-30Amerfresh Fluoride Toothpaste
70766-003-082023-01-30Amerfresh Fluoride Toothpaste
70766-003-092023-01-30Amerfresh Fluoride Toothpaste
70766-003-102023-01-30Amerfresh Fluoride Toothpaste
70766-003-112023-01-30Amerfresh Fluoride Toothpaste
70766-003-122023-01-30Amerfresh Fluoride Toothpaste
70766-003-132023-01-30Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-003-01Amerfresh17 g in 1 TUBEPASTE1710
70766-003-01Amerfresh144 in 1 BOXPASTE14410
70766-003-02Amerfresh144 in 1 BOXPASTE14410
70766-003-02Amerfresh24 g in 1 TUBEPASTE2410
70766-003-03Amerfresh144 in 1 BOXPASTE14410
70766-003-03Amerfresh43 g in 1 TUBEPASTE4310
70766-003-04Amerfresh144 in 1 BOXPASTE14410
70766-003-04Amerfresh78 g in 1 TUBEPASTE7810
70766-003-05Amerfresh85 g in 1 TUBEPASTE8510
70766-003-05Amerfresh144 in 1 BOXPASTE14410
70766-003-06Amerfresh142 g in 1 TUBEPASTE14210
70766-003-06Amerfresh144 in 1 BOXPASTE14410
70766-003-07Amerfresh7 g in 1 BAGPASTE710
70766-003-07Amerfresh1000 in 1 BOXPASTE100010
70766-003-08Amerfresh5 in 1 CARTONPASTE510
70766-003-08Amerfresh144 in 1 BOXPASTE14410
70766-003-09Amerfresh5 in 1 CARTONPASTE510
70766-003-09Amerfresh144 in 1 BOXPASTE14410
70766-003-10Amerfresh7.1 g in 1 BAGPASTE7.110
70766-003-10Amerfresh1000 in 1 BOXPASTE100010
70766-003-11Amerfresh72 in 1 BOXPASTE7210
70766-003-11Amerfresh142 g in 1 TUBEPASTE14210
70766-003-12Amerfresh181 g in 1 TUBEPASTE18110
70766-003-12Amerfresh72 in 1 BOXPASTE7210
70766-003-13Amerfresh125 in 1 BOXPASTE12510
70766-003-13Amerfresh4 in 1 CARTONPASTE410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-003AMERFRESH (SODIUM FLUORIDE) PASTE [YANGZHOU SION COMMODITY CO.,LTD]10Legacy NDC, 26 package rows20231208_41f32cae-e80d-2e25-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-003-0170766000301144 TUBE in 1 BOX (70766-003-01) > 17 g in 1 TUBE144 tube2016-05-250000-00-00NoNoCurrent
70766-003-0270766000302144 TUBE in 1 BOX (70766-003-02) > 24 g in 1 TUBE144 tube2016-05-250000-00-00NoNoCurrent
70766-003-0370766000303144 TUBE in 1 BOX (70766-003-03) > 43 g in 1 TUBE144 tube2016-05-250000-00-00NoNoCurrent
70766-003-0470766000304144 TUBE in 1 BOX (70766-003-04) > 78 g in 1 TUBE144 tube2016-05-250000-00-00NoNoCurrent
70766-003-0570766000305144 TUBE in 1 BOX (70766-003-05) > 85 g in 1 TUBE144 tube2016-06-180000-00-00NoNoCurrent
70766-003-0670766000306144 TUBE in 1 BOX (70766-003-06) > 142 g in 1 TUBE144 tube2016-06-180000-00-00NoNoCurrent
70766-003-07707660003071000 BAG in 1 BOX (70766-003-07) > 7 g in 1 BAG1000 bag2016-06-180000-00-00NoNoCurrent
70766-003-08707660003085 BOX in 1 CARTON (70766-003-08) > 144 TUBE in 1 BOX > 17 g in 1 TUBE5 box2016-11-230000-00-00NoNoCurrent
70766-003-09707660003095 BOX in 1 CARTON (70766-003-09) > 144 TUBE in 1 BOX > 24 g in 1 TUBE5 box2016-11-230000-00-00NoNoCurrent
70766-003-10707660003101000 BAG in 1 BOX (70766-003-10) > 7.1 g in 1 BAG1000 bag2016-06-180000-00-00NoNoCurrent
70766-003-117076600031172 TUBE in 1 BOX (70766-003-11) > 142 g in 1 TUBE72 tube2016-06-180000-00-00NoNoCurrent
70766-003-127076600031272 TUBE in 1 BOX (70766-003-12) > 181 g in 1 TUBE72 tube2016-06-180000-00-00NoNoCurrent
70766-003-13707660003134 BOX in 1 CARTON (70766-003-13) > 125 TUBE in 1 BOX > 5 g in 1 TUBE4 box2017-12-180000-00-00NoNoCurrent