Walgreens Sensitive Enamel Repair

Product NDC
0363-0593
11-digit product format
003630593
Labeler code
0363
Product ID
0363-0593_47f5bce2-57ad-de07-e063-6394a90a51d9
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Walgreens
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-08
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Walgreens Sensitive Enamel Repair
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41d6384d-695b-b60b-e063-6394a90aa0b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0593-10Walgreens Sensitive Enamel Repair96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
0363-0593-10Walgreens Sensitive Enamel Repair1 in 1 CARTONPASTE, DENTIFRICE12

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 34 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN41d6384d-695b-b60b-e063-6394a90aa0b92
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD41d6384d-695b-b60b-e063-6394a90aa0b92
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY41d6384d-695b-b60b-e063-6394a90aa0b92
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY41d6384d-695b-b60b-e063-6394a90aa0b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0593-10003630593101 TUBE in 1 CARTON (0363-0593-10) / 96.4 g in 1 TUBE1 tube2026-01-08NoNoCurrent