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 33 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola Ag	229a7feb-c646-4557-85e5-0832682ab926	2024-12-05	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola Ag	0e135eb0-4a40-4930-ade4-fb7df87db1f4	2024-12-05	Warnings	Exact identifier application number: M022
Cherry Throat Drops	MENTHOL	Ricola Ag	73d767e2-bb80-4eff-8420-500c2a4067aa	2024-12-05	Warnings	Exact identifier application number: M022
COOL RELIEF ORAL ANESTHETIC	MENTHOL	Ricola Ag	951e9836-e6a3-4094-8a6b-f226c85c897a	2024-12-05	Warnings	Exact identifier application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETIC	MENTHOL	Ricola Ag	908f5ce5-94a4-4c35-ae7a-b308ea37fa08	2024-12-05	Warnings	Exact identifier application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPS	MENTHOL	Ricola Ag	a6657ecf-e74a-4912-a68c-73abc456f9e2	2024-12-05	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola Ag	67373cf1-e8c3-4db2-98e1-c88d25a76209	2024-12-05	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola Ag	586b2a46-2673-4f27-a62a-2d48a9b520ab	2024-12-05	Warnings	Exact identifier application number: M022
BERRY MEDLEY THROAT DROPS	MENTHOL	Ricola Ag	a2bdd035-4678-4cff-b24f-8e2f06acad96	2024-12-05	Warnings	Exact identifier application number: M022
Orajel Toothache Rinse	BENZYL ALCOHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	41709710-5392-3119-e054-00144ff88e88	2024-11-27	Warnings	Exact identifier application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore Rinse	HYDROGEN PEROXIDE, MENTHOL	Church & Dwight Co., Inc.	99d47d6a-fa2e-d5ee-e053-2995a90aa11d	2024-11-27	Warnings	Exact identifier application number: M022
Orajel 2x Gum Pain Alcohol-Free	MENTHOL AND HYDROGEN PEROXIDE	Church & Dwight Co., Inc.	adf37010-922c-4441-93d6-1e1a95025e90	2024-11-27	Warnings	Exact identifier application number: M022
Maximum Strength Cold Sore Treatment	CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM	Meijer Distribution Inc	9220772c-b3b7-4855-e053-2a95a90a94f6	2024-11-27	Warnings	Exact identifier application number: M022
Peroxyl Mouth Sore Mild Mint	HYDROGEN PEROXIDE	Colgate Oral Pharmaceuticals Inc.	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	2024-11-25	Warnings	Exact identifier application number: M022
NICE SORE THROAT Spearmint	PHENOL	Leosons Overseas Corp	5fc68f04-ec15-11c0-e053-2a91aa0a1952	2024-11-20	Warnings	Exact identifier application number: M022
TANAC Oral Pain Reliever	BENZOCAINE	Leosons Overseas Corp	81cc61fa-31a7-2214-e053-2a91aa0ae46a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Honey Lemon	PHENOL	Leosons Overseas Corp	601aea98-e6ab-de6f-e053-2a91aa0a824a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Cherry	PHENOL	Leosons Overseas Corp	5f21694c-d1c9-0e64-e053-2a91aa0a0ff0	2024-11-15	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL	Safeway, Inc.	f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d	2024-11-14	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry	PHENOL	Best Choice (Valu Merchandisers Company)	c0a47d59-3e15-453d-97a7-d626e8650862	2024-11-14	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