FDA.reportPublic FDA data

Dr. Jen SuperPaste Ortho

Product NDC
84181-359
11-digit product format
841810359
Labeler code
84181
Product ID
84181-359_22708540-3c27-4dc6-8720-9486b752eb7c
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Dr Jen Natural, LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-13
Substance
SODIUM FLUORIDE
Active strength
.22 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dr. Jen SuperPaste Ortho
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.22 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9dd248bf-9488-43cd-a041-e8315a05ce5dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84181-359-09Dr. Jen SuperPaste Ortho1 in 1 BOXPASTE, DENTIFRICE11
84181-359-09Dr. Jen SuperPaste Ortho100 mL in 1 TUBEPASTE, DENTIFRICE1001

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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINTSODIUM FLUORIDEColgate-Palmolive Company9aaa451d-8827-41b7-9661-bc1a7a69cfc32026-06-30WarningsExact identifier
application number: M021
CrestPlus Deep Clean plus Whitening Effervescent MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5579be77-97df-1000-e063-6294a90a47252026-06-30WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTHSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company358842de-3e1d-4f66-8d08-fe8538441b342026-06-29WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited5356d0a8-2db4-ce7f-e063-6394a90aa6d22026-06-26WarningsExact identifier
application number: M021
Colgate Optic White Renewal Brilliant ShineSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company70734d67-fc3e-4515-b6e6-ab2c466578d62026-06-26WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Companyf87d6f04-507a-47ae-8a66-204cf59261c02026-06-26WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513ba92-cadc-2cf3-e063-6294a90ac3e52026-06-25WarningsExact identifier
application number: M021
Crest Plus Active Fresh Scope plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513e40f-b8e8-2d9a-e063-6394a90ab1702026-06-25WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Mint SplashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6c690e-a1bb-4606-e063-6394a90ac4b62026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bbc3d-a1f9-b278-e063-6294a90a62f72026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bd56c-dac8-eb87-e063-6294a90a3cc12026-06-25Exact identifier
application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0b1d46-d52c-f409-e063-6394a90a55742026-06-25Exact identifier
application number: M021
Crest Plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5514e09e-0a7d-93e6-e063-6294a90ae3f02026-06-25WarningsExact identifier
application number: M021
Colgate Sparkling White Mint ZingSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company0c2fe62b-4905-4213-a85b-e073d8eeb7412026-06-24WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Company890c4c29-bba8-4775-a053-10c6292df9302026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55004d9d-eda7-a285-e063-6294a90ad4ca2026-06-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.5500686c-d417-c50a-e063-6294a90ac7fa2026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5500f9ab-b0c4-51d6-e063-6394a90acd382026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5504ec96-aae1-f5f9-e063-6294a90ad8bb2026-06-24WarningsExact identifier
application number: M021
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN9dd248bf-9488-43cd-a041-e8315a05ce5d1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD9dd248bf-9488-43cd-a041-e8315a05ce5d1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY9dd248bf-9488-43cd-a041-e8315a05ce5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84181-359-09841810359091 TUBE in 1 BOX (84181-359-09) / 100 mL in 1 TUBE1 tube2024-03-13NoNoCurrent