Antiseptic Oral Rinse

Product NDC: 53462-175
11-digit product format: 534620175
Labeler code: 53462
Product ID: 53462-175_55068435-9db1-0599-e063-6294a90abea5
Type: HUMAN OTC DRUG
Nonproprietary name: CETYLPYRIDINIUM CHLORIDE
Dosage form: MOUTHWASH
Route: BUCCAL
Labeler: Sage Products LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-06-21
Substance: CETYLPYRIDINIUM CHLORIDE
Active strength: .5 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: Antiseptic Oral Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETYLPYRIDINIUM CHLORIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D9OM4SK49P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1251617	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
efff8bae-154d-46bc-8dd4-716800425663	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53462-175-30	2022-02-23	Antiseptic Oral Rinse
53462-175-30	2022-02-23	Antiseptic Oral Rinse
53462-175-60	2022-02-23	Antiseptic Oral Rinse
53462-175-60	2022-02-23	Antiseptic Oral Rinse
53462-175-30	2022-01-28	Antiseptic Oral Rinse
53462-175-30	2022-01-28	Antiseptic Oral Rinse
53462-175-60	2022-01-28	Antiseptic Oral Rinse
53462-175-60	2022-01-28	Antiseptic Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53462-175-60	Antiseptic Oral Rinse	7 mL in 1 PACKET	MOUTHWASH	7		11
53462-175-60	QCare Petite Size Oral Cleansing and Suctioning System	7 mL in 1 PACKET	MOUTHWASH	42 mL in 6	0.5 mg in 1mL	4
53462-175-60	Suction Toothbrushes	7 mL in 1 PACKET	MOUTHWASH	7 mL	0.5 mg in 1mL	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cetylpyridinium chloride	ACTIVE INGREDIENT	D9OM4SK49P	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
cetylpyridinium	ACTIVE MOIETY	CUB7JI0JV3	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
peppermint	INACTIVE INGREDIENT	V95R5KMY2B	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]	2
CETYLPYRIDINIUM CHLORIDE	ACTIVE INGREDIENT	D9OM4SK49P	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
CETYLPYRIDINIUM	ACTIVE MOIETY	CUB7JI0JV3	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53462-175	ANTISEPTIC ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC]	9	Current NDC, Legacy NDC, 1 package rows	20241120_efff8bae-154d-46bc-8dd4-716800425663.zip
53462-175	QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]	4	Current NDC, Legacy NDC	20190118_b08bc4f9-85db-b57c-5e1d-97e3383acf18.zip
53462-175	SUCTION TOOTHBRUSHES (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]	3	Current NDC, Legacy NDC	20180426_9f81731e-6343-49e0-a2b4-e8269d6bcd6a.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D9OM4SK49P	CETYLPYRIDINIUM CHLORIDE	6004-24-6	CETYLPYRIDINIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	efff8bae-154d-46bc-8dd4-716800425663	11
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	efff8bae-154d-46bc-8dd4-716800425663	11
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	efff8bae-154d-46bc-8dd4-716800425663	11
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	b08bc4f9-85db-b57c-5e1d-97e3383acf18	4
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	b08bc4f9-85db-b57c-5e1d-97e3383acf18	4
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	b08bc4f9-85db-b57c-5e1d-97e3383acf18	4
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	9f81731e-6343-49e0-a2b4-e8269d6bcd6a	3
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	9f81731e-6343-49e0-a2b4-e8269d6bcd6a	3
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	9f81731e-6343-49e0-a2b4-e8269d6bcd6a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53462-175-60	53462017560	7 mL in 1 PACKET (53462-175-60)	7 ml	2001-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antiseptic Oral Rinse	Sage Products LLC	2026-06-24	HUMAN OTC DRUG LABEL	12
QCare Petite Size Oral Cleansing and Suctioning System	Sage Products, LLC	2019-01-17	HUMAN OTC DRUG LABEL	4
Suction Swab System	Sage Products LLC	2018-04-26	HUMAN OTC DRUG LABEL	3
Suction Toothbrushes	Sage Products LLC	2018-04-26	HUMAN OTC DRUG LABEL	3