FDA.reportPublic FDA data

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 22:24:17

Label at a glance#

ProductOral-B Anticavity
Active ingredientSodium Fluoride
Label structure11 sections

Dosage and administration

Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste. Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without ...

Storage and handling

Store above freezing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - DO NOT USE SECTION

Do not use if shrinkband is broken or missing.

OTC - WHEN USING SECTION

Do not swallow.

If more than amount used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste.
  • Vigorously swish 10ml (as indicated inside cap) of rinse between your teeth for 1 minute then spit out. Do not swallow.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits to minimize swallowing.
  • Supervise children as necessary until capable of using without supervision.
  • Consult a dentist or physician for use by children under 6 years of age.

Other information

STORAGE AND HANDLING SECTION

Store above freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG 40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate, Potassium Sorbate, Phosphoric Acid, Sodium Saccharin, FD&C Blue #1

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
© Oral-B Laboratories

Made in Colombia

PRINCIPAL DISPLAY PANEL - 500ml Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oral -B®

Anticavity Fluoride Rinse

  • Reduces dental cavities by
    up to 40% over brushing alone
  • Alcohol-free

NATURAL
MINT
FLAVOR

16.9 oz / 500ml

Principal Display Panel - 500ml Label
Principal Display Panel - 500ml Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831841Oral-B Anticavity 0.05 % Oral RinsePSN1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
831841sodium fluoride 0.5 MG/ML Mouthwash [Oral B Anti-Cavity]SBD1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
831841Oral B Anti-Cavity 0.05 % MouthwashSY1
831841Oral B Anti-Cavity 0.5 MG/ML MouthwashSY1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0041-1421-162019-10-21C16284748780-1956f9ecf-db33-621f-e053-dbdaa90a74adOral-B® Anticavity Fluoride Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0041-1421-16Oral-B Anticavity500 mL in 1 BOTTLE, PLASTICLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0041-1421ORAL-B (SODIUM FLUORIDE) LIQUID [ORAL-B LABORATORIES]1Legacy NDC, 1 package rows20100420_d8336ad5-d1fb-4290-9433-d852405d1409.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride ionACTIVE MOIETYQ80VPU408O1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0041-14210041-1421-16

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
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
64705480-a0f6-4765-8dc4-7ae64816d3a4d8336ad5-d1fb-4290-9433-d852405d14092010-04-02WarningsExact identifier
spl id: 64705480-a0f6-4765-8dc4-7ae64816d3a4
spl set id: d8336ad5-d1fb-4290-9433-d852405d1409

Reported adverse events (FAERS/openFDA)#

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