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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toms of Maine Whiten Plus Deep Clean Peppermint	SODIUM FLUORIDE	Tom's of Maine	4c535776-3f80-4eeb-bb63-2d734c3c3a6b	2026-02-18	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	581d5cdb-018a-42ad-899d-5331f0063376	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021 ndc (product): 0363-0163

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