Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Manufacturer: Dr. Fresh LLC
Effective date: 2020-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:46:22

Label at a glance#

ProductFirefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 6 years of age and older. Use once a day after brushing your teeth with a toothpaste. 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 untill capable of us...

Contacts and useful links#

PhoneLabel contact1-866-373-7374

Websitewww.drfresh.com

www.drfresh.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose:

OTC - PURPOSE SECTION

Anticavity Rinse

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

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. 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 untill capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, Bubble Gum Flavor, polysorbate 80, propylene glycol, FDandC Red No. 33, sodium benzoate, sodium phosphate monobasic, sodium saccharin, sorbitol, water, xylitol.

Question? Comments?

OTC - QUESTIONS SECTION

DR.Fresh

Toll Free. 1-866-373-7374

comments@defresh.com

visit us online at:

www.drfresh.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Firefly Mouth Swoosh

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64893-300-00	2021-09-22	C162847	48780-1	c7ccaba7-1d73-fd44-e053-dadaa90aa01b	Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse
64893-300-01	2021-09-22	C162847	48780-1	c7ccaba7-1d73-fd44-e053-dadaa90aa01b	Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse
64893-300-00	2021-07-23	C162847	48780-1	c7ccaba7-1d73-fd44-e053-dadaa90aa01b	Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse
64893-300-01	2021-07-23	C162847	48780-1	c7ccaba7-1d73-fd44-e053-dadaa90aa01b	Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	2
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse
SODIUM FLUORIDE
CETYLPYRIDINIUM CHLORIDE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
POLYSORBATE 80
PROPYLENE GLYCOL
D&C RED NO. 33
SODIUM BENZOATE
SACCHARIN SODIUM
SORBITOL
WATER
XYLITOL
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64893-300	64893-300-00, 64893-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	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 8 · 468 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 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
53678308-48bc-4f51-b26d-0566d214ea4b			d6a63944-6efc-4c31-aa50-029bf5ca9811	2021-09-22	Warnings	Exact identifier spl set id: d6a63944-6efc-4c31-aa50-029bf5ca9811

Reported adverse events (FAERS/openFDA)#

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