ACT Restoring Anticavity Fluoride Mouthwash Cool Mint

Manufacturer: Chattem, Inc.
Effective date: 2026-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 01:32:12

Label at a glance#

ProductACT Restoring Anticavity Fluoride Cool Mint

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Dosage and administration

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing ...

Contacts and useful links#

Websitewww.actfluoride.com

www.actfluoride.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

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 once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat or drink 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

SPL UNCLASSIFIED SECTION

do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1 (245-167)

www.actfluoride.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED
BRAND FOR STRENGTHENING ENAMEL
ACT
RESTORING
ANTICAVITY FLUORIDE MOUTHWASH
COOL MINT
18 fl oz (532 mL)

#1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 18 fl oz (532 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
656809	ACT 0.05 % (fluoride ion 0.02 % ) Mouthwash	PSN	11
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	11
656809	sodium fluoride 0.5 MG/ML Mouthwash [ACT Fluoride Rinse]	SBD	11
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	11
656809	ACT Fluoride Rinse 0.05 % (as fluoride ion 0.02 % ) Mouthwash	SY	11
656809	ACT Fluoride Rinse 0.5 MG/ML Mouthwash	SY	11
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	11

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	897006		act-restoring-anticavity-fluoride-mouthwash-cool-m-01.jpg
Data code	Data Matrix	897008		act-restoring-anticavity-fluoride-mouthwash-cool-m-01.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41167-0957-5	ACT Restoring Anticavity Fluoride Cool Mint	532 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	532		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	6
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	6
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	6
EDETATE CALCIUM DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8U5D034955	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	6
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	6
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	6
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

ACT Restoring Anticavity Fluoride Cool Mint
sodium fluoride
FLUORIDE ION
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM PHOSPHATE
POLYSORBATE 20
SACCHARIN SODIUM
CETYLPYRIDINIUM CHLORIDE
EDETATE CALCIUM DISODIUM ANHYDROUS
FD&C BLUE NO. 1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-0957	41167-0957-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	IACT
EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT

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 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE CALCIUM DISODIUM ANHYDROUS	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION, SOLUTION / INTRAVASCULAR	0.05 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii+dosage form 14 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii+route 16 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	CAPSULE / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CREAM / TOPICAL		13 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	CREAM / TOPICAL	NA		Exact identifier — unii+route 8 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii+route 18 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	SOLUTION / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	SOLUTION / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOAP / TOPICAL	0.21 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii+route 10 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	CAPSULE, EXTENDED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii+route 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
EDETATE CALCIUM DISODIUM ANHYDROUS	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
EDETATE CALCIUM DISODIUM ANHYDROUS	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION, SOLUTION / INTRAVASCULAR	0.05 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
EDETATE CALCIUM DISODIUM ANHYDROUS	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRA-ARTERIAL		23 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii+dosage form 14 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii+route 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii+route 24 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii+route 42 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDE	CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	CAPSULE, EXTENDED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 42 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii+route 16 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOAP / TOPICAL	0.21 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 14 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CREAM / TOPICAL		13 mg	Exact identifier — unii+route 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	MOUTHWASH / BUCCAL	NA		Exact identifier — unii+dosage form 8 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
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	ef63e193-5804-4b35-bae7-cad29cf4e8bc	2026-01-12	Warnings	Exact identifier ndc (package): 41167-0957-5 ndc (product): 41167-0957 ndc11 (package): 41167095705 spl id: e957eb42-3732-49b1-93e2-456b5f9a9447 spl set id: ef63e193-5804-4b35-bae7-cad29cf4e8bc

Reported adverse events (FAERS/openFDA)#

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