Oral-B

Manufacturer: Oral-B Laboratories
Effective date: 2010-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:24:16

Label at a glance#

ProductOral-B Anti-Bacterial

Active ingredientCetylpyridinium Chloride

Label structure11 sections

Dosage and administration

Rinse twice daily, after brushing, with 1/2 a capful (15 ml) for about 30 seconds.

Storage and handling

Store above freezing.

Contacts and useful links#

PhoneLabel contact1-800-56-ORALB

Websitewww.oralb.com

www.oralb.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Anti-bacterial

Use

INDICATIONS & USAGE SECTION

To fight plaque and bad breath bacteria.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Not for use by children under six years of age.

Children over six should be supervised when using this product.

OTC - DO NOT USE SECTION

Do not use if shrinkband is broken or missing.

OTC - WHEN USING SECTION

Do not swallow.

Directions

DOSAGE & ADMINISTRATION SECTION

Rinse twice daily, after brushing, with 1/2 a capful (15 ml) for about 30 seconds.

Other information

STORAGE AND HANDLING SECTION

Store above freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Alcohol (9.3%), Flavor, Poloxamer 407, Methylparaben, Sodium Saccharin, Propylparaben, FD&C Blue #1, and D&C Yellow #10

Question or comments?

OTC - QUESTIONS SECTION

1-800-56-ORALB
www.oralb.com

SPL UNCLASSIFIED SECTION

Distributed by:
Oral-B, A Division of
Procter & Gamble
Cincinnati, OH 45202

Made in Colombia

PRINCIPAL DISPLAY PANEL - 500ml Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral -B®

Anti-Bacterial Rinse

Dual action formula kills
plaque and bad breath
bacteria on contact

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1251617	cetylpyridinium chloride 0.05 % Mouthwash	PSN	1
1251617	cetylpyridinium chloride 0.5 MG/ML Mouthwash	SCD	1
1251617	cetylpyridinium chloride 0.05 % Mouthwash	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0041-1420-16	2019-10-21	C162847	48780-1	956f9ecf-c180-621f-e053-dbdaa90a74ad	Oral -B® Anti-Bacterial Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0041-1420-16	Oral-BAnti-Bacterial	500 mL in 1 BOTTLE, PLASTIC	LIQUID	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0041-1420	ORAL-B ANTI-BACTERIAL (CETYLPYRIDINIUM CHLORIDE) LIQUID [ORAL-B LABORATORIES]	1	Legacy NDC, 1 package rows	20100420_89bfbf53-8da7-4d88-b051-aa6789a0eaec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
Cetylpyridinium Chloride	ACTIVE INGREDIENT	D9OM4SK49P	1
Cetylpyridinium	ACTIVE MOIETY	CUB7JI0JV3	1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Oral-B Anti-Bacterial
Cetylpyridinium Chloride
Cetylpyridinium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0041-1420	0041-1420-16

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Cetylpyridinium Chloride	D9OM4SK49P	ACTIB

Source Document#

Source XML

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
fdb37c8d-9768-4e34-a17a-27124a0895ca			89bfbf53-8da7-4d88-b051-aa6789a0eaec	2010-04-02	Warnings	Exact identifier spl id: fdb37c8d-9768-4e34-a17a-27124a0895ca spl set id: 89bfbf53-8da7-4d88-b051-aa6789a0eaec

Reported adverse events (FAERS/openFDA)#

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