Mouth Rinse

Manufacturer: Walgreen Co. | Nice-Pak Products, LLC
Effective date: 2026-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 01:45:52

Label at a glance#

ProductMouth Rinse

Active ingredientSODIUM FLUORIDE

Label structure12 sections

Dosage and administration

Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink anything for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until cap...

Storage and handling

store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F) cold weather may temporarily cloud this product

Contacts and useful links#

PhoneLabel contact1-800-925-4733

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

for this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink anything for 30 minutes after rinsing
instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Questions

OTC - QUESTIONS SECTION

Call 1-800-925-4733

Disclaimers

SPL UNCLASSIFIED SECTION

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.

‡This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered trademark Listerine .

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD, DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

DSP-TN-21091

DSP-MO-20087

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in Listerine ^®Total Care Anticavity Mouthwash‡

Anticavity Rinse

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

Restores Enamel

Freshens Breath

Helps prevent cavities
Strengthen teeth
Kills bad breath germs

Eucalyptus Mint flavor

33.8 fl oz (1 L)

IMPORTANT: Read directions for proper use

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1038904	sodium fluoride 0.0221 % (fluoride ion 0.01 % ) Mouthwash	PSN	16
1038904	sodium fluoride 0.221 MG/ML Mouthwash	SCD	16
1038904	sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral Rinse	SY	16

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	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Mouth Rinse
sodium fluoride
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
EUCALYPTOL
METHYL SALICYLATE
MENTHOL
PHOSPHORIC ACID
SACCHARIN SODIUM
THYMOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SUCRALOSE
FD&C RED NO. 40
FD&C BLUE NO. 1
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0163	0363-0163-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
EUCALYPTOL	RV6J6604TK	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
MENTHOL	L7T10EIP3A	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
THYMOL	3J50XA376E	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 318 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 10 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 10 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii+route 46 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route 52 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii+route 46 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 36 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 10 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 36 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii+route 14 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii+route 52 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route 52 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii+route 46 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	MOUTHWASH / BUCCAL	0.01 mg/1ml		Exact identifier — unii+dosage form 52 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 14 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii+route 52 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 52 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii+route 52 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route 46 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 14 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii+route 46 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii+route 14 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii+route 10 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii+route 14 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii+route 52 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	Exact identifier ndc (package): 0363-0163-86 ndc (product): 0363-0163 ndc11 (package): 00363016386 spl id: 4aa46dbb-3e7c-cd84-e063-6394a90ad744 spl set id: eae87899-3eba-4d50-bc31-9eaf54ff9e00

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.