FDA.reportPublic FDA data

Rite Aid

Product NDC
11822-5020
11-digit product format
118225020
Labeler code
11822
Product ID
11822-5020_439577bb-c84a-eca0-e063-6394a90a9246
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Rite Aid
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-03
Marketing end
2027-01-01
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
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
Rite Aid
Brand name suffix
Extra Whitening

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
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efe2c6c1-b8c6-4a52-b3c6-c9bfca450570Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5020-9Rite AidExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11314
11822-5020-9Rite AidExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7RITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
FLUORIDE IONACTIVE MOIETYQ80VPU408ORITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
NITRATE IONACTIVE MOIETYT93E9Y2844RITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9RITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SORBITOLINACTIVE INGREDIENT506T60A25RRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
WATERINACTIVE INGREDIENT059QF0KO0RRITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEERITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5020RITE AID EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [RITE AID]12Current NDC, Legacy NDC, 2 package rows20250119_efe2c6c1-b8c6-4a52-b3c6-c9bfca450570.zip

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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
application number: M022
SEXYTEETH MINTY T00THPASTESEXYTEETH MINTY TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51d288c1-fe86-ffe1-e063-6394a90ab4c42026-05-14WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat cherryBENZOCAINE AND MENTHOLReckitt Benckiser LLC941e36dd-d8d0-4e5c-8585-10e8f06bf8f02026-05-12WarningsExact identifier
application number: M022
Cepacol Extra Strength Sore Throat honey lemonBENZOCAINE AND MENTHOLReckitt Benckiser LLCd771095b-7de3-48f3-a125-8bc76e7d17782026-05-12WarningsExact identifier
application number: M022
SEXYTEETH CHARCOAL T00THPASTESEXYTEETH CHARCOAL TOOTHPASTEWORLD DENTISTS ASSOCIATION AMERICA LIMITED51ab8a9a-6c12-b13b-e063-6294a90ace2a2026-05-12WarningsExact identifier
application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash AnticavityFLUORIDEWHOLE FOODS25bc7ab1-116d-143a-e063-6394a90aa9702026-05-04WarningsExact identifier
application number: M022
Gingicaine Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
application number: M022
3ECARE Dual formula WhiteningToothpaste RefillSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.501df1c7-4884-bb39-e063-6294a90aaf6a2026-04-23WarningsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Inc1f10a72f-0b49-41cb-92f9-b0160d7664de2026-04-22WarningsExact identifier
application number: M022
EverSmile AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
application number: M022
PREOPHYDROGEN PEROXIDEEverbrands, Inc.cc5cdd29-92c1-4ce0-997e-eb624b288b092026-04-20WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINECVSa7576238-e7c8-7e86-e053-2995a90aaeb52026-04-20WarningsExact identifier
application number: M022
CVS Pharmacy Maximum StrengthBENZOCAINECVS Pharmacy92747826-cf58-4406-b3b5-12f7c7077c2c2026-04-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
application number: M022
Osstem S Sensitivity relief toothPOTASSIUM NITRATE, SODIUM FLUORIDEOsstem Pharma Co., Ltd4f8ab179-8f29-a7cf-e063-6294a90a0c222026-04-15WarningsExact identifier
application number: M022
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsExact identifier
application number: M022
Lolleez Orange MangoPECTINBFY LLC4f6dec8b-078a-f321-e063-6294a90a248c2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsExact identifier
application number: M022
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYefe2c6c1-b8c6-4a52-b3c6-c9bfca45057014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5020-9118225020091 TUBE in 1 CARTON (11822-5020-9) / 113 g in 1 TUBE1 tube2013-06-032027-01-01NoNoCurrent