FDA.reportPublic FDA data

Oral B Minute-Foam

Manufacturer
YOUNG DENTAL MANUFACTURING CO 1, LLC
Effective date
2023-01-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 20:45:57

Label at a glance#

ProductOral B Minute-Foam Bubble Gum
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

Minute-Foam® is a flavored aqueous foaming solution of acidulated phosphate sodium fluoride with an optimized low pH and a fluoride ion

concentration of 1.23% w/w.

Inactives

INACTIVE INGREDIENT SECTION

  • Purified water
  • Poloxamer 407
  • Cocamidoprophyl betaine
  • Xylitol, sucralose
  • Sodiumphosphate monobasic
  • Flavor

Warnings

WARNINGS SECTION

  •  DO NOT SWALLOW.
  • Keep out of reach of children. In the event more than the treatment dose is swallowed, administer calcium (e.g.milk) and get medical help or contact a Poison Control Center right away. Avoid spraying towards open flame.
  • Contents under pressure. Do not puncture or incinerate. Do not expose to heat.
  • Store at temperatures between 59-86°F
  • (15-30°C). Keep from freezing.

Product Label for Minute-Foam Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bubble gumbubble gum

Product Label for Minute-Foam Mellow Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mellow MintMellow Mint

Product Label for Minute-Foam Orange-A-Tangy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oragneoragne

Product Label for Minute-Foam Strawberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

strawberrystrawberry

Product Label for Mint-Foam Grape

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

grapegrape

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831834sodium fluoride 2.2 % / hydrofluoric acid 0.5 % Oral FoamPSN6
831834hydrofluoric acid 5 MG/ML / sodium fluoride 22 MG/ML Oral FoamSCD6
831834sodium fluoride 2.2 % / hydrofluoric acid 0.5 % Oral FoamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0273-0341-062025-01-30C16284748780-12cef2736-70f1-d83d-e063-dadaa90ab31fOral B Minute-Foam Soultion
0273-0342-062025-01-30C16284748780-12cef2736-70f1-d83d-e063-dadaa90ab31fOral B Minute-Foam Soultion
0273-0345-062025-01-30C16284748780-12cef2736-70f1-d83d-e063-dadaa90ab31fOral B Minute-Foam Soultion
0273-0346-062025-01-30C16284748780-12cef2736-70f1-d83d-e063-dadaa90ab31fOral B Minute-Foam Soultion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0273-0341-06Oral B Minute-FoamMellow Mint165 g in 1 BOTTLESOLUTION1656
0273-0342-06Oral B Minute-FoamOrange-A-Tangy165 g in 1 BOTTLESOLUTION1656
0273-0345-06Oral B Minute-FoamBubble Gum165 g in 1 BOTTLESOLUTION1656
0273-0346-06Oral B Minute-FoamStrawberry165 g in 1 BOTTLESOLUTION1656
0273-0347-06Oral B Minute-FoamGrape165 g in 1 BOTTLESOLUTION1656

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-0341ORAL B MINUTE-FOAM BUBBLE GUM (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM MELLOW MINT (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM ORANGE-A-TANGY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM STRAWBERRY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM GRAPE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC]6Legacy NDC, 1 package rows20230105_836627d4-44fb-4a21-a641-7c18569258bb.zip
0273-0342ORAL B MINUTE-FOAM BUBBLE GUM (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM MELLOW MINT (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM ORANGE-A-TANGY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM STRAWBERRY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM GRAPE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC]6Legacy NDC, 1 package rows20230105_836627d4-44fb-4a21-a641-7c18569258bb.zip
0273-0345ORAL B MINUTE-FOAM BUBBLE GUM (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM MELLOW MINT (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM ORANGE-A-TANGY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM STRAWBERRY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM GRAPE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC]6Legacy NDC, 1 package rows20230105_836627d4-44fb-4a21-a641-7c18569258bb.zip
0273-0346ORAL B MINUTE-FOAM BUBBLE GUM (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM MELLOW MINT (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM ORANGE-A-TANGY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM STRAWBERRY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM GRAPE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC]6Legacy NDC, 1 package rows20230105_836627d4-44fb-4a21-a641-7c18569258bb.zip
0273-0347ORAL B MINUTE-FOAM BUBBLE GUM (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM MELLOW MINT (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM ORANGE-A-TANGY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM STRAWBERRY (SODIUM FLUORIDE) SOLUTION ORAL B MINUTE-FOAM GRAPE (SODIUM FLUORIDE) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC]61 package rows20230105_836627d4-44fb-4a21-a641-7c18569258bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KX1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M21
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WaterINACTIVE INGREDIENT059QF0KO0R1
xylitolINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0273-03450273-0345-06
0273-03410273-0341-06
0273-03420273-0342-06
0273-03460273-0346-06
0273-03470273-0347-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
XYLITOLVCQ006KQ1EIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
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 1 · 58 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / INTRATYMPANIC63 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2LOTION / TOPICAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / TOPICAL14.2 mgExact identifier — unii candidate
9 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.2 mgExact identifier — unii candidate
9 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSOLUTION / ORAL25 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / PERIODONTAL155 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CREAM / TOPICAL13 mgExact identifier — unii candidate
15 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2GEL / TOPICAL28 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWTABLET / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
9 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CAPSULE / ORAL468 mgExact identifier — unii candidate
15 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii candidate
15 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
xylitolXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 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
f1621bba-8cfa-26d6-e053-2a95a90ac1db836627d4-44fb-4a21-a641-7c18569258bb2023-01-03WarningsExact identifier
spl id: f1621bba-8cfa-26d6-e053-2a95a90ac1db
spl set id: 836627d4-44fb-4a21-a641-7c18569258bb

Reported adverse events (FAERS/openFDA)#

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