MedPath

Oral B Minute-Foam

Oral B Minute-Foam Soultion

Approved
Approval ID

836627d4-44fb-4a21-a641-7c18569258bb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2023

Manufacturers
FDA

YOUNG DENTAL MANUFACTURING CO 1, LLC

DUNS: 006309355

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0273-0347
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0273-0342
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0273-0346
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0273-0341
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification

INGREDIENTS (7)

SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0273-0345
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2023
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 12.3 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT

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Oral B Minute-Foam - FDA Drug Approval Details