MediChoice Premium Anticavity Fluoride

Product NDC: 39892-0603
11-digit product format: 398920603
Labeler code: 39892
Product ID: 39892-0603_40b23569-3539-20aa-e063-6394a90ae6ea
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: O&M HALYARD, INC.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-03-01
Substance: SODIUM FLUORIDE
Active strength: 2.43 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: MediChoice Premium Anticavity Fluoride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	2.43 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891775	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c6ba9b51-b958-4836-adc8-871529a43fc6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
39892-0603-2	MediChoice Premium Anticavity Fluoride	24 g in 1 TUBE	PASTE, DENTIFRICE	24		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE	INACTIVE INGREDIENT	B70850QPHR	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
39892-0603	MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR]	5	Current NDC, Legacy NDC, 1 package rows	20231213_c6ba9b51-b958-4836-adc8-871529a43fc6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Advanced Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	cef9a30c-a18c-47e9-b276-f56608f0400f	2024-10-01	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	86c4b51e-b086-4566-8f94-a951bf0c6254	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total Whitening Fresh Boost	STANNOUS FLUORIDE	Colgate-Palmolive Company	c436382e-2755-c882-2970-4be1b9ca537b	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Gel	STANNOUS FLUORIDE	Colgate-Palmolive Company	27c4eed5-9121-4e09-9d42-e0a3e8430109	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	56434e3d-ba0a-8b42-6c97-0d0055606793	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Mint Stripe Gel	STANNOUS FLUORIDE	Colgate-Palmolive Company	abfbcacd-9c1a-4472-9e91-a85e78050a9e	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Advanced Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	f8aeac8e-6a3e-4ada-bb13-db337b934ba3	2024-09-27	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef	2024-09-27	Warnings	Exact identifier application number: M021
Colgate Total SF Advanced Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	92642408-4465-4f8f-85f9-cf12aadc147b	2024-09-27	Warnings	Exact identifier application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios Inc.	b197ac2d-f9d6-4937-a0a6-2f425e4c3796	2024-09-26	Warnings	Exact identifier application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc	dc04ee5c-3561-4579-8f9b-00266a8c8871	2024-09-25	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)	SODIUM FLUORIDE	MADE BY DENTISTS INC	94939abe-b05e-4ea2-a1a6-204da857b4aa	2024-09-18	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Arctic Blast	SODIUM FLUORIDE	Chattem, Inc.	2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57	2024-08-22	Warnings	Exact identifier application number: M021
CinnaFresh	SODIUM FLUORIDE	Bob Barker Company Inc.	3fbd95f0-a10c-4351-ad80-7e90b2d6a6f5	2024-08-22	Warnings	Exact identifier application number: M021
Karl and Hans Botanic Double Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	d1233fc3-047c-4e26-bb2b-8ebde09c05a9	2024-08-08	Warnings	Exact identifier application number: M021
Karl and Hans Botanic Jasmine	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	6c0335e6-f041-48c7-9da3-88c124b84b00	2024-08-08	Warnings	Exact identifier application number: M021
OMNI	STANNOUS FLUORIDE	Solventum US LLC	0c2a81b1-65b5-432b-8e66-30432a245aba	2024-08-01	Warnings	Exact identifier application number: M021
Just For Kids	STANNOUS FLUORIDE	Solventum US LLC	0f1afc36-f699-4072-b90b-c9f5be989a49	2024-08-01	Warnings	Exact identifier application number: M021
Clinpro Tooth Creme	SODIUM FLUORIDE	Solventum US LLC	786c6184-6bc8-4376-9ce2-3e35af193210	2024-08-01	Warnings	Exact identifier application number: M021
PerioMed	STANNOUS FLUORIDE	Solventum US LLC	7f79eb00-86df-4284-b415-47f45e4849da	2024-08-01	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
891775	sodium fluoride 0.243 % Toothpaste	PSN	c6ba9b51-b958-4836-adc8-871529a43fc6	6
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	c6ba9b51-b958-4836-adc8-871529a43fc6	6
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	c6ba9b51-b958-4836-adc8-871529a43fc6	6
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	c6ba9b51-b958-4836-adc8-871529a43fc6	6
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	c6ba9b51-b958-4836-adc8-871529a43fc6	6
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	c6ba9b51-b958-4836-adc8-871529a43fc6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
39892-0603-2	39892060302	24 g in 1 TUBE (39892-0603-2)	24 g	2013-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MediChoice Premium Anticavity Fluoride Toothpaste	O&M HALYARD, INC. \| Owens & Minor, Inc \| Dabur India Limited	2025-10-08	HUMAN OTC DRUG LABEL	6