FDA.reportPublic FDA data

Amerfresh

Product NDC
70766-002
Requested package NDC
70766-002-05
11-digit product format
707660002
Labeler code
70766
Product ID
70766-002_d332a469-d256-e8a3-e053-2995a90a42e0
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
DENTAL
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 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 packagepackage70766-00270766-002-05IInactivated by FDA2026-10-12

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
70766-002-012023-12-08Amerfresh Fluoride Toothpaste
70766-002-022023-12-08Amerfresh Fluoride Toothpaste
70766-002-032023-12-08Amerfresh Fluoride Toothpaste
70766-002-042023-12-08Amerfresh Fluoride Toothpaste
70766-002-052023-12-08Amerfresh Fluoride Toothpaste
70766-002-062023-12-08Amerfresh Fluoride Toothpaste
70766-002-072023-12-08Amerfresh Fluoride Toothpaste
70766-002-082023-12-08Amerfresh Fluoride Toothpaste
70766-002-092023-12-08Amerfresh Fluoride Toothpaste
70766-002-102023-12-08Amerfresh Fluoride Toothpaste
70766-002-112023-12-08Amerfresh Fluoride Toothpaste
70766-002-122023-12-08Amerfresh Fluoride Toothpaste
70766-002-012023-01-30Amerfresh Fluoride Toothpaste
70766-002-022023-01-30Amerfresh Fluoride Toothpaste
70766-002-032023-01-30Amerfresh Fluoride Toothpaste
70766-002-042023-01-30Amerfresh Fluoride Toothpaste
70766-002-052023-01-30Amerfresh Fluoride Toothpaste
70766-002-062023-01-30Amerfresh Fluoride Toothpaste
70766-002-072023-01-30Amerfresh Fluoride Toothpaste
70766-002-082023-01-30Amerfresh Fluoride Toothpaste
70766-002-092023-01-30Amerfresh Fluoride Toothpaste
70766-002-102023-01-30Amerfresh Fluoride Toothpaste
70766-002-112023-01-30Amerfresh Fluoride Toothpaste
70766-002-122023-01-30Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-002-01Amerfresh17 g in 1 TUBEPASTE1710
70766-002-01Amerfresh144 in 1 BOXPASTE14410
70766-002-02Amerfresh24 g in 1 TUBEPASTE2410
70766-002-02Amerfresh144 in 1 BOXPASTE14410
70766-002-03Amerfresh43 g in 1 TUBEPASTE4310
70766-002-03Amerfresh144 in 1 BOXPASTE14410
70766-002-04Amerfresh144 in 1 BOXPASTE14410
70766-002-04Amerfresh78 g in 1 TUBEPASTE7810
70766-002-05Amerfresh85 g in 1 TUBEPASTE8510
70766-002-05Amerfresh144 in 1 BOXPASTE14410
70766-002-06Amerfresh142 g in 1 TUBEPASTE14210
70766-002-06Amerfresh144 in 1 BOXPASTE14410
70766-002-07Amerfresh1000 in 1 BOXPASTE100010
70766-002-07Amerfresh7 g in 1 BAGPASTE710
70766-002-08Amerfresh144 in 1 BOXPASTE14410
70766-002-08Amerfresh5 in 1 CARTONPASTE510
70766-002-09Amerfresh5 in 1 CARTONPASTE510
70766-002-09Amerfresh144 in 1 BOXPASTE14410
70766-002-10Amerfresh1000 in 1 BOXPASTE100010
70766-002-10Amerfresh7.1 g in 1 BAGPASTE7.110
70766-002-11Amerfresh142 g in 1 TUBEPASTE14210
70766-002-11Amerfresh72 in 1 BOXPASTE7210
70766-002-12Amerfresh181 g in 1 TUBEPASTE18110
70766-002-12Amerfresh72 in 1 BOXPASTE7210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-002AMERFRESH (SODIUM FLUORIDE) PASTE [YANGZHOU SION COMMODITY CO.,LTD]10Legacy NDC, 24 package rows20231208_3f735eed-d9e6-2720-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN3f735eed-d9e6-2720-e054-00144ff88e8810
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3f735eed-d9e6-2720-e054-00144ff88e8810
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3f735eed-d9e6-2720-e054-00144ff88e8810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-002-0570766000205144 TUBE in 1 BOX (70766-002-05) > 85 g in 1 TUBE144 tube2016-06-180000-00-00NoNoCurrent