FDA.reportPublic FDA data

AdoptaPlatoon

Product NDC
70766-007
Requested package NDC
70766-007-01
11-digit product format
707660007
Labeler code
70766
Product ID
70766-007_d921c849-a1ee-5dda-e053-2995a90a163c
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 packagepackage70766-00770766-007-01IInactivated by FDA2026-10-12

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-007-01AdoptaPlatoon10 g in 1 TUBEPASTE, DENTIFRICE102
70766-007-01AdoptaPlatoon30 in 1 BOXPASTE, DENTIFRICE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-007ADOPTAPLATOON (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]2Legacy NDC, 2 package rows20231208_0a491d55-03cc-4e26-aaf6-5e9c77d74fc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN0a491d55-03cc-4e26-aaf6-5e9c77d74fc52
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD0a491d55-03cc-4e26-aaf6-5e9c77d74fc52
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY0a491d55-03cc-4e26-aaf6-5e9c77d74fc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70766-007-017076600070130 TUBE in 1 BOX (70766-007-01) > 10 g in 1 TUBE30 tube2022-02-280000-00-00NoNoCurrent