MedPath

Quality Choice

5820029 QC Nat White Ex Sens

Approved
Approval ID

8d187823-7e56-441b-8bca-8f03e7bb07c7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

CHAIN DRUG MARKETING ASSOCIATION INC

DUNS: 011920774

Products 1

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

Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63868-172
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (14)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80J
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM METHYL COCOYL TAURATEInactive
Code: JVL98CG53G
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.15 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
POTASSIUM NITRATEActive
Quantity: 5 g in 100 g
Code: RU45X2JN0Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/7/2012

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/7/2012

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/7/2012

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/7/2012

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS SECTION

LOINC: 34071-1Updated: 11/7/2012

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/7/2012

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 11/7/2012

Other Information

Store in a cool dry place. Keep tube capped when not in use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/7/2012

Inactive ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

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Quality Choice - FDA Drug Approval Details