Rite Aid

Product NDC
11822-6020
11-digit product format
118226020
Labeler code
11822
Product ID
11822-6020_441ecfa5-d2c2-ef78-e063-6394a90a5014
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Rite Aid
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-03
Marketing end
2027-01-24
Substance
SODIUM FLUORIDE; POTASSIUM NITRITE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct11822-6020UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-602011822-6020-9UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Enamel Guard

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRITE5 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
794654G42LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67c1fc04-0f21-4944-8b9d-0d8ffd051874Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-6020-9Rite AidEnamel Guard113 g in 1 TUBEPASTE, DENTIFRICE11325
11822-6020-9Rite AidEnamel Guard1 in 1 CARTONPASTE, DENTIFRICE125

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRITEACTIVE INGREDIENT794654G42LRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7RITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
FLUORIDE IONACTIVE MOIETYQ80VPU408ORITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
NITRITE IONACTIVE MOIETYJ39976L608RITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9RITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
SORBITOLINACTIVE INGREDIENT506T60A25RRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
WATERINACTIVE INGREDIENT059QF0KO0RRITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEERITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6020RITE AID ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [RITE AID]23Current NDC, Legacy NDC, 2 package rows20250403_67c1fc04-0f21-4944-8b9d-0d8ffd051874.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN67c1fc04-0f21-4944-8b9d-0d8ffd05187425
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD67c1fc04-0f21-4944-8b9d-0d8ffd05187425
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY67c1fc04-0f21-4944-8b9d-0d8ffd05187425
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY67c1fc04-0f21-4944-8b9d-0d8ffd05187425
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY67c1fc04-0f21-4944-8b9d-0d8ffd05187425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-6020-9118226020091 TUBE in 1 CARTON (11822-6020-9) / 113 g in 1 TUBE1 tube2013-06-032027-01-24NoNoCurrent