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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden Sensitive Care Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	3fb153f1-ba6e-7251-e063-6294a90abe62	2025-09-26	Warnings	Exact identifier application number: M021
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	DONG IL PHARMS CO.,LTD	3fb1a2ee-381e-a9e8-e063-6394a90a864b	2025-09-26	Warnings	Exact identifier application number: M021
unpa Cha Cha Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Lycl Inc.	230b3cf2-053a-4e8b-8d50-05bbc877faa8	2025-09-25	Warnings	Exact identifier application number: M021
TheraBreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c5d58f1-ea8c-4708-bbc6-21e1cd1446da	2025-09-19	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1	2025-09-18	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	c1bbdd36-53fb-43a3-ba20-afbeb6359d31	2025-09-18	Warnings	Exact identifier application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	f70d378b-d4d6-454c-90a9-794459960c8c	2025-09-17	Warnings	Exact identifier application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21	2025-09-16	Warnings	Exact identifier application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	3436532d-e078-4dbb-a823-b4542e961534	2025-09-16	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Fresh Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	9b1671c4-8680-6e2a-9f10-0400840ca5a9	2025-09-12	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	ddc09ce5-181a-1b50-7094-314bb58a15cf	2025-09-12	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint Anticavity Mouthwash	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	3efc66b2-fcf9-4d26-9cdd-1af8225312b4	2025-09-10	Warnings	Exact identifier application number: M021
CLOSE UP Freshening with Mouthwash	SODIUM FLUORIDE	Church & Dwight Co., Inc.	e660b0d7-4cc5-4028-bdf5-016b85899728	2025-09-09	Warnings	Exact identifier application number: M021
Essentials Healthy Teeth and Gums	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	9652c004-6b47-840f-e053-2995a90a6e98	2025-09-09	Warnings	Exact identifier application number: M021
Complete Care Whole Mouth Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	d00f9d16-de0e-4ffc-e053-2a95a90a2069	2025-09-09	Warnings	Exact identifier application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	e911effb-d59f-4054-9501-803b64369ab4	2025-09-05	Warnings	Exact identifier application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	HISMILE PTY LTD	3de10638-1a39-b747-e063-6294a90a4ca5	2025-09-03	Warnings	Exact identifier application number: M021
Optimax Purple Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8264e849-a6b3-4953-a85b-da9d4e7f5a70	2025-09-02	Warnings	Exact identifier application number: M021
CAREKON ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.	3baca3b6-ff48-0579-e063-6394a90abd08	2025-08-29	Warnings	Exact identifier application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc.	fc794fe5-7135-4b2b-b002-a75908223f20	2025-08-13	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