Rx only · Paste · Oral

Sodium Fluoride

Brands: Biotene Fresh Mint Original · Biotene Gentle Mint · Maximum Security Anticavity Gel Fresh Mint Flavor · Morning Fresh +3 · Sodium Monofluorophosphate

5 ACTIVE SUPPLIERS — US

openFDA · updated weekly

US7 NDCs
5 active makers

UKComing
soon

CAComing
soon

AUComing
soon

EUComing
soon

ATCA01AA01

RxCUI (US)9873

US makers5 labelers

Packages11

DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it5 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Haleon US Holdings LLC	unknown	4	SUPPLYING
SPARROW LIFE CARE PRIVATE LIMITED	unknown	2	SUPPLYING
Church & Dwight Co., Inc.	unknown	2	SUPPLYING
Dynarex Corporation	unknown	2	SUPPLYING
Massco Dental A Division of Dunagin Pharmaceuticals	unknown	1	SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Jul 15, 2015
RECALLRecall (Class II): biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan,…
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. — Recalling firm: GlaxoSmithkline Consmer Healthcare — Nationwide, Puerto Rico & Taiwan
Jul 15, 2015
RECALLRecall (Class II): biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.7…
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. — Recalling firm: GlaxoSmithkline Consmer Healthcare — Nationwide, Puerto Rico & Taiwan