FDA.reportPublic FDA data

Amerfresh

Product NDC
70766-001
Requested package NDC
70766-001-01
11-digit product format
707660001
Labeler code
70766
Product ID
70766-001_b61f6044-86c6-328d-e053-2a95a90a9f7e
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 MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage70766-00170766-001-01IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70766-00170766-001-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70766-00170766-001-01IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70766-00170766-001-01IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
70766-001-012026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-022026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-032026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-042026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-052026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-062026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-072026-01-2970766-001 Amerfresh Fluoride Toothpaste
70766-001-012023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-022023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-032023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-042023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-052023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-062023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-072023-12-0870766-001 Amerfresh Fluoride Toothpaste
70766-001-012022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-022022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-032022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-042022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-052022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-062022-01-2870766-001 Amerfresh Fluoride Toothpaste
70766-001-072022-01-2870766-001 Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-001-01Amerfresh144 in 1 BOXPASTE1445
70766-001-01Amerfresh17 g in 1 TUBEPASTE175
70766-001-02Amerfresh144 in 1 BOXPASTE1445
70766-001-02Amerfresh24 g in 1 TUBEPASTE245
70766-001-03Amerfresh43 g in 1 TUBEPASTE435
70766-001-03Amerfresh144 in 1 BOXPASTE1445
70766-001-04Amerfresh78 g in 1 TUBEPASTE785
70766-001-04Amerfresh144 in 1 BOXPASTE1445
70766-001-05Amerfresh144 in 1 BOXPASTE1445
70766-001-05Amerfresh85 g in 1 TUBEPASTE855
70766-001-06Amerfresh142 g in 1 TUBEPASTE1425
70766-001-06Amerfresh144 in 1 BOXPASTE1445
70766-001-07Amerfresh7 g in 1 BAGPASTE75
70766-001-07Amerfresh1000 in 1 BOXPASTE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-001AMERFRESH (SODIUM FLUORIDE) PASTE [YANGZHOU SION COMMODITY CO.,LTD]5Legacy NDC, 14 package rows20231208_35df5050-2215-4b1d-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN35df5050-2215-4b1d-e054-00144ff8d46c5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD35df5050-2215-4b1d-e054-00144ff8d46c5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY35df5050-2215-4b1d-e054-00144ff8d46c5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY35df5050-2215-4b1d-e054-00144ff8d46c5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY35df5050-2215-4b1d-e054-00144ff8d46c5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY35df5050-2215-4b1d-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-001-0170766000101144 TUBE in 1 BOX (70766-001-01) > 17 g in 1 TUBE144 tube2016-05-250000-00-00NoNoCurrent