FDA.reportPublic FDA data

Orajel Anticavity Fluoride Rinse

Manufacturer
Church & Dwight Canada Corp. | Church & Dwight Co., Inc. | Church & Dwight Co., Inc
Effective date
2016-04-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:27:20

Label at a glance#

ProductOrajel Anticavity Fluoride Rinse Alcohol and Sugar Free
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium Fluoride 0.02%

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 6 years of age and older

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoons) of rinse between your teeth for at least 1 minute then spit out
  • do not swallow the rinse
  • 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

Children under 6 years of age consult a dentist or doctor

OTHER SAFETY INFORMATION

Other Information do not use if safety seal is broken or missing

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, sorbitol, poloxamer 407, polysorbate 20, phenylcarbinol, sodium bicarbonate, flavor, sodium benzoate, xylitol, cetylpyridinium chloride, sodium saccharin, blue 1

OTC - QUESTIONS SECTION

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com

Orajel Anticavity Fluoride Rinse Alcohol & Sugar Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orajel

Anticavity Fluoride Rinse

Alcohol & Sugar Free

Fun-tastic Fruit

  • Fights Cavities & Strengthens Enamel
  • Cleans Where Brushing May Miss
  • Made with Micro-Cleansers

IMPORTANT: Read directions for proper use . 6+ Years

16.9 FL OZ (500mL)

OJLBB-42993-02OJLBB-42993-02

OJLBF-42993-02OJLBF-42993-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M21
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62864-91062864-910-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
XYLITOLVCQ006KQ1EIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 334 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE / ORAL468 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
34 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PCAPSULE / ORAL2 mgExact identifier — unii candidate
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PSOLUTION / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAMUSCULAR54 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates

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
9b047136-2bbd-1466-e053-2a95a90a5a9821714d36-5b85-3124-e054-00144ff8d46c2019-12-31WarningsExact identifier
spl set id: 21714d36-5b85-3124-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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