FDA.reportPublic FDA data

Pronamel Repair Whitening

Manufacturer
Rite Aid | Lornamead Products
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:17:31

Label at a glance#

ProductPronamel Repair Whitening
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity

WARNINGS SECTION

When using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if the problem persists or worsens.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity stil persists after 4 weeks of use.

OTC - PURPOSE SECTION

Anthihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentaly swallowed, get medical help or contact a Posion Control Center right away.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older: apply at least a 1-inch strip of the product ontp 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2821076R1 Rite Aid Enamel Guard2821076R1 Rite Aid Enamel Guard

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN3
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD3
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822020145GTIN-13: 0011822020145
EAN-13: 0011822020145
GTIN-12: 011822020145
UPC-A: 011822020145
GTIN storage (14 digits): 00011822020145		Rite Aid Enamel GUard 5820076 2821076R1 Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-6310-1Pronamel Repair Whitening96 g in 1 TUBEPASTE, DENTIFRICE963
11822-6310-1Pronamel Repair Whitening1 in 1 CARTONPASTE, DENTIFRICE13

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-631011822-6310-1

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
POTASSIUM NITRATERU45X2JN0ZACTIB

Source Document#

Source XML

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
Pronamel Repair WhiteningFLUORIDERite Aid21645dd5-5cb7-2088-e063-6394a90a61ff2025-11-21WarningsExact identifier
ndc (package): 11822-6310-1
ndc (product): 11822-6310
ndc11 (package): 11822631001
spl id: 441ef4c5-4903-159d-e063-6394a90aebd0
spl set id: 21645dd5-5cb7-2088-e063-6394a90a61ff

Reported adverse events (FAERS/openFDA)#

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