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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitive Teeth and Gums	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	935172db-d78f-0c69-e053-2a95a90a0b69	2026-07-23	Warnings	Exact identifier application number: M021
Essentials Whiten and Strengthen	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	96548550-2cd1-b757-e053-2995a90a15ea	2026-07-23	Warnings	Exact identifier application number: M021
TP COL OW Purple	SODIUM FLUORIDE	Colgate-Palmolive Company	ea0db59f-f9c0-49a8-9717-69cdf071f6e1	2026-07-23	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	00652bb2-090c-4eaa-8fc2-e0be6913a724	2026-07-22	Warnings	Exact identifier application number: M021
Colgate Ultra White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	95d06fcc-f56d-43f1-924a-3f91fda59bdf	2026-07-22	Warnings	Exact identifier application number: M021
COLGATE Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	730f40f6-6ac6-49bd-888b-c0b5818a03c8	2026-07-20	Warnings	Exact identifier application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POP	SODIUM FLUORIDE	Colgate-Palmolive Company	bf465181-01e9-44ca-91f8-03110a606774	2026-07-16	Warnings	Exact identifier application number: M021
Colgate Minions Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	16634b99-f305-48bf-ac54-a9f53797a9e5	2026-07-16	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	Dabur India Limited	56aaa9f5-7eac-11d9-e063-6294a90af3a8	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	Dabur India Limited	56aaba60-523e-6ac7-e063-6394a90a2756	2026-07-15	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	Dabur India Limited	56aac050-73e7-298c-e063-6294a90a26eb	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	Dabur India Limited	56aac7a7-c086-2fa5-e063-6294a90aa959	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	Dabur India Limited	56aad223-db88-7cf6-e063-6394a90a6b72	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	MKJ BRANDS LLC	2dcd4816-caa5-c006-e063-6394a90ac487	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	DABUR INDIA LIMITED	56acecd2-6966-2ee4-e063-6394a90a356f	2026-07-15	Warnings	Exact identifier application number: M021
Colgate Max Fresh Advanced Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	01c07c25-2748-4d90-9505-094e2c977c9c	2026-07-15	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d51c67b-7409-e5a7-e053-2a91aa0a81fa	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	476f453b-9215-0a11-e063-6294a90a5cd4	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	525662da-42be-eaa6-e063-6294a90af110	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	MKJ BRANDS LLC	526acbdd-6531-692d-e063-6394a90ab9f1	2026-07-14	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