BreathAway

Manufacturer: Melaleuca, Inc.
Effective date: 2023-01-30
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 23:53:35

Label at a glance#

ProductBreathAway Mouth Rinse Fresh Mint

Active ingredientCETYLPYRIDINIUM CHLORIDE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

Purpose
Antigingivitis/Antiplaque

INDICATIONS & USAGE SECTION

Uses

helps prevent gingivitis
helps prevent plaque that leads to gingivitis

WARNINGS SECTION

Warnings
Stop use and ask a dentist if symptoms persist or condition worsens after regular use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and older: vigorously swish 20 mL (4 teaspoonfuls) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
children 6 years to under 12 years of age: supervise use.
children under 6 years of age: do not use

INACTIVE INGREDIENT SECTION

Inactive ingredients
water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1100928	Breath-Away 0.07 % Oral Rinse	PSN	6
1100924	cetylpyridinium chloride 0.07 % Oral Rinse	PSN	6
1100928	cetylpyridinium chloride 0.7 MG/ML Mouthwash [Breath-Away]	SBD	6
1100924	cetylpyridinium chloride 0.7 MG/ML Mouthwash	SCD	6
1100928	Breath-Away 0.07 % Mouth Rinse	SY	6
1100928	Breath-Away 0.7 MG/ML Mouthwash	SY	6
1100924	cetylpyridinium chloride 0.07 % Oral Rinse	SY	6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-294-08	2025-01-30	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint
54473-294-16	2025-01-30	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint
54473-294-08	2020-03-19	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint
54473-294-16	2020-03-19	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint
54473-294-08	2020-01-31	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint
54473-294-16	2020-01-31	C162847	48780-1	9d75b9d0-1174-f424-e053-dadaa90a57ce	BreathAway Mouth Rinse Fresh Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-294-08	BreathAwayMouth Rinse Fresh Mint	237 mL in 1 BOTTLE	MOUTHWASH	237		6
54473-294-16	BreathAwayMouth Rinse Fresh Mint	473 mL in 1 BOTTLE	MOUTHWASH	473		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-294	BREATHAWAY MOUTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [MELALEUCA, INC.]	6	Legacy NDC, 2 package rows	20230131_37b2c031-ecc9-4420-9d84-e71c0e529187.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETYLPYRIDINIUM CHLORIDE	ACTIVE INGREDIENT	D9OM4SK49P	2
CETYLPYRIDINIUM	ACTIVE MOIETY	CUB7JI0JV3	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
ETHYL MENTHANE CARBOXAMIDE	INACTIVE INGREDIENT	6S7S02945H	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
MYRRH OIL	INACTIVE INGREDIENT	H74221J5J4	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	2
ZINC CITRATE	INACTIVE INGREDIENT	K72I3DEX9B	2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

BreathAway Mouth Rinse Fresh Mint
Cetylpyridinium Chloride
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
ETHYL MENTHANE CARBOXAMIDE
GLYCERIN
MYRRH OIL
POLOXAMER 407
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLYSORBATE 20
POTASSIUM SORBATE
SODIUM BENZOATE
SODIUM HYDROXIDE
SORBITOL
TEA TREE OIL
WATER
XYLITOL
ZINC CITRATE
CETYLPYRIDINIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-294	54473-294-16, 54473-294-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ETHYL MENTHANE CARBOXAMIDE	6S7S02945H	IACT
GLYCERIN	PDC6A3C0OX	IACT
MYRRH OIL	H74221J5J4	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SORBITOL	506T60A25R	IACT
TEA TREE OIL	VIF565UC2G	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
ZINC CITRATE	K72I3DEX9B	IACT
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	ACTIB

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 9 · 489 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / ORAL		3240 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	LOTION / TOPICAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CREAM / TOPICAL		13 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	GUM, CHEWING / BUCCAL		147 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, FILM COATED / ORAL	1.75 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTERSTITIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	CAPSULE, COATED / ORAL	101.25 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 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
f38399eb-d483-44aa-e053-2a95a90ab96e			37b2c031-ecc9-4420-9d84-e71c0e529187	2023-01-30	Warnings	Exact identifier spl id: f38399eb-d483-44aa-e053-2a95a90ab96e spl set id: 37b2c031-ecc9-4420-9d84-e71c0e529187

Reported adverse events (FAERS/openFDA)#

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