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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Total Care Zero Alcohol Anticavity Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	4b594a6e-db1d-443b-bfa7-23ee15749f47	2024-12-19	Warnings	Exact identifier application number: M021
NewYork-Presbyterian Amenity	SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	4b307471-445d-4c51-a499-d074a8172f20	2024-12-17	Warnings	Exact identifier application number: M021
Colgate Anticavity	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive (Thailand) Limited - Branch	5bc0b430-6f68-4e52-a1da-de19136eaeac	2024-12-09	Warnings	Exact identifier application number: M021
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	03ec09f9-4281-9ccb-e063-6294a90aadd8	2024-12-01	Warnings	Exact identifier application number: M021
CURODONT PROTECT	STANNOUS FLUORIDE	CREDENTIS AG	03ec591c-68c3-a380-e063-6394a90a131a	2024-12-01	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Bubble Gum Blowout	SODIUM FLUORIDE	Chattem, Inc.	61f3a3e6-645b-4368-b1d5-7de1fc14542e	2024-12-01	Warnings	Exact identifier application number: M021
SparkleFresh Flouride Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Medline Industries, LP	1565528b-89f2-4c97-b294-15b6ebd3f80e	2024-11-26	Warnings	Exact identifier application number: M021
Rembrandt Intense Stain	SODIUM FLUORIDE	Ranir LLC	55dcd063-5661-35aa-e054-00144ff8d46c	2024-11-26	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	9f98913f-6754-4e1c-98cf-b89fe87750f8	2024-11-25	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	88f87f7a-5b2d-47c9-8830-6b88b4ddbb59	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	0c85d273-3b98-43ea-81ba-c90f70ab72f8	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	2a882210-49e6-4b9c-a2c6-eaa37b6514c3	2024-11-25	Warnings	Exact identifier application number: M021
Pepsodent Complete Care Original	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c6931cb-0ec9-41bb-b410-c355573aab57	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Strawberry Natural Fluoride	SODIUM FLUORIDE	Ranir LLC	8ee37955-fe1a-4964-ac29-d1d7dfb694cc	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	abdc7f79-5f87-4307-8ddd-e6281ac67a04	2024-11-20	Warnings	Exact identifier application number: M021
AIM Bubble Berry	SODIUM FLUORIDE	Church & Dwight Co., Inc.	c83ccdea-d75f-4084-853e-ed4bab9a12d4	2024-11-20	Warnings	Exact identifier application number: M021
AIM TARTAR CONTROL Plus Mouthwash and Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fc71c-d28e-4afa-e054-00144ff8d46c	2024-11-20	Warnings	Exact identifier application number: M021
Advance White Tartar Control Breath Freshening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	aa8be8f5-ba46-4b1b-afaa-58fddf8f8780	2024-11-20	Warnings	Exact identifier application number: M021
Enamel Defense	SODIUM FLUORIDE	Church & Dwight Co., Inc.	9e8f1ce9-b161-50db-e053-2995a90ad32b	2024-11-20	Warnings	Exact identifier application number: M021
Rembrandt Deeply White Plus Peroxide	SODIUM MONOFLUOROPHOSPHATE	Ranir LLC	bf7da007-ab9d-4631-bc28-6ca245fd6265	2024-11-20	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