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 10 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d721e2cb-8f67-3d07-e053-2995a90ae65a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advantage	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	ddcd56fe-25d6-8195-e053-2a95a90a575a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dc1f31-625d-a032-e053-2995a90a730d	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro Health Gum plus Bacteria Guard	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c598a4ab-5981-0068-e053-2a95a90af4fa	2026-01-08	Warnings	Exact identifier application number: M022
Oral B Gum Detoxify Special Care Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	c2dcdde4-5542-1f87-e053-2995a90a261c	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Fresh Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	62991165-ec81-48a8-e053-2991aa0a54f3	2026-01-08	Warnings	Exact identifier application number: M022
Crest Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	72f1a02f-1d02-7e83-e053-2a91aa0a7947	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Intense Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	6287bc3e-8b05-45d3-e053-2991aa0aaa10	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	8867d791-7e93-4f39-aaaf-bfbee8296fd9	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	HEB	a71c5259-cbcf-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
Topco Associates LLC Maximum Strength	FLUORIDE	Topco Associates LLC	387d264c-90cc-5e67-e063-6394a90a713d	2026-01-08	Warnings	Exact identifier application number: M022
TopCare Sensitive Extra Whitening	POTASSIUM NITRATE, SODIUM FLUORIDE	TOPCO Assoc. LLC	835f41cf-e920-7df7-e053-2a91aa0a4479	2026-01-08	Warnings	Exact identifier application number: M022
Scope Icy Blast	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	164ed151-01d3-021a-e063-6294a90a0e51	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Advanced Enamel Care	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1660e7d7-5b8d-8aba-e063-6294a90a50d8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Deep Cleanse Germ Treatment	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	2d6b15d4-7827-ec2f-e063-6294a90a82c8	2026-01-08	Warnings	Exact identifier application number: M022
Crest Scope Original	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	21eed451-9368-146c-e063-6294a90af62b	2026-01-08	Warnings	Exact identifier application number: M022
3x Medicated Mouth Sore Gel	BENZOCAINE	HEB	a71c5259-cbd1-7566-e053-2995a90a2cb6	2026-01-08	Warnings	Exact identifier application number: M022
HEB Extra Whitening	FLUORIDE	HEB	b76c3591-6383-4661-b3db-7a56b11202f7	2026-01-08	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