Mouth Rinse

Product NDC: 36800-001
11-digit product format: 368000001
Labeler code: 36800
Product ID: 36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Topco Associates LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-12-30
Substance: SODIUM FLUORIDE
Active strength: .1 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Mouth Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.1 mg/mL

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
1038904	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
c640adc0-e178-4b6a-af44-07d2f7da81d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-001-86	Mouth Rinse	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-001	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]	15	Current NDC, Legacy NDC, 1 package rows	20250323_c640adc0-e178-4b6a-af44-07d2f7da81d3.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 44 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	Warnings	Exact identifier application number: M021
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

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
1038904	sodium fluoride 0.0221 % (fluoride ion 0.01 % ) Mouthwash	PSN	c640adc0-e178-4b6a-af44-07d2f7da81d3	16
1038904	sodium fluoride 0.221 MG/ML Mouthwash	SCD	c640adc0-e178-4b6a-af44-07d2f7da81d3	16
1038904	sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral Rinse	SY	c640adc0-e178-4b6a-af44-07d2f7da81d3	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-001-86	36800000186	1000 mL in 1 BOTTLE, PLASTIC (36800-001-86)	1000 ml	2010-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 163.005/163AG Anticavity Fluoride Rinse	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	16