MedPath

Sensitive Extra Whitening

5820075 Publix Sensitive Extra Whitening (8015201)

Approved
Approval ID

16eddce3-03e4-4c0e-e063-6294a90ae94d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Publix Super Market

DUNS: 006922009

Products 1

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 Code56062-413
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (13)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM METHYL COCOYL TAURATEInactive
Code: JVL98CG53G
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.15 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIM
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
POTASSIUM NITRATEActive
Quantity: 5 g in 100 g
Code: RU45X2JN0Z
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/4/2024

Publix Sensitive

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2024

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2024

Potassium nitrate 5%

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/4/2024

Antihypersensitivity

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2024

When using this product, if irritation occurs discontinue.

Stop use and ask a dentist if * the problem persists or worsen. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity still persists after 4 weeks of use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/4/2024

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2024

adults and children 12 years pf age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. * children under 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2024

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

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Sensitive Extra Whitening - FDA Drug Approval Details