Mouth Rinse

Product NDC: 0363-0163
11-digit product format: 003630163
Labeler code: 0363
Product ID: 0363-0163_4aa46dbb-3e7c-cd84-e063-6394a90ad744
Type: HUMAN OTC DRUG
Nonproprietary name: sodium fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Walgreen Co.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-03-15
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
eae87899-3eba-4d50-bc31-9eaf54ff9e00	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-0163-86	2023-10-13	C162847	48780-1	f386c649-e915-0266-e053-dadaa90a7c1a	Walgreens 163.005/163AF-AG Anticavity Mouth Rinse
0363-0163-86	2023-01-30	C162847	48780-1	f386c649-e915-0266-e053-dadaa90a7c1a	Walgreens 163.005/163AF-AG Anticavity Mouth Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-0163-86	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 [WALGREEN]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0163	MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [WALGREEN]	14	Current NDC, Legacy NDC, 1 package rows	20240716_eae87899-3eba-4d50-bc31-9eaf54ff9e00.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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE STRAWBERRY BURST	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	08d7ed04-67a4-437a-82c5-496f9893c6c7	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	27278b02-c4fd-4092-a632-a14e442f5a95	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	59a6b9ac-c28b-4ec3-8231-f35054ce0eaf	2026-08-10	Warnings	Exact identifier application number: M021
Toms Kids Watermelon Wiggle	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	64b60e74-fceb-4de9-a966-73bf8dbd666c	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	7e880d50-8aab-4d57-abc1-e900070f9a11	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	5cb5eb46-705c-4bb7-bef1-e93a598636fd	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	0e043431-9d87-478d-87f5-5aa8b0a932eb	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	19de1e71-ab94-415f-b66d-e5748dea8317	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	d5e1396e-0253-4ec0-a9ff-b61bda70de35	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED COOL MILD MINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	de92408c-d401-47c3-94ee-fb6c08092651	2026-08-10	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	eae87899-3eba-4d50-bc31-9eaf54ff9e00	16
1038904	sodium fluoride 0.221 MG/ML Mouthwash	SCD	eae87899-3eba-4d50-bc31-9eaf54ff9e00	16
1038904	sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral Rinse	SY	eae87899-3eba-4d50-bc31-9eaf54ff9e00	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0163-86	00363016386	1000 mL in 1 BOTTLE, PLASTIC (0363-0163-86)	1000 ml	2006-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens 163.005/163AF-AG Anticavity Mouth Rinse	Walgreen Co. \| Nice-Pak Products, LLC	2026-02-12	HUMAN OTC DRUG LABEL	16