Freshen Up

Product NDC
77782-005
11-digit product format
777820005
Labeler code
77782
Product ID
77782-005_56964f07-211c-29b1-e063-6394a90a214f
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE, POTASSIUM NITRATE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
MKJ BRANDS LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-02
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.76 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
Freshen Up
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
476f453b-9215-0a11-e063-6294a90a5cd4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77782-005-20Freshen Up2 in 1 BOXGEL, DENTIFRICE21
77782-005-20Freshen Up99 g in 1 BOTTLEGEL, DENTIFRICE991

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 39 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
application number: M021
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
application number: M021
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
application number: M021
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.303d4ad0-5a2b-347a-e063-6394a90aa0ba2025-04-07WarningsExact identifier
application number: M021
OralLine KidsSODIUM FLUORIDEJ.M. Murray Center Inc.12c5bee5-e228-4f71-9bfd-c377ee2372a92025-03-21WarningsExact identifier
application number: M021
AdoptaPlatoonSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDc1592b56-cf3d-4a4d-be84-e40eb3f1456e2025-03-21WarningsExact identifier
application number: M021
OralLine SecureSODIUM FLUORIDEJ.M. Murray Center Inc.4c0970e9-7417-4234-89e3-3b602a609af52025-03-20WarningsExact identifier
application number: M021
Crayola ANTICAVITY BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios, Inc.ec66246f-06e2-4da1-b9d5-ce2a7815ffd12025-03-19WarningsExact identifier
application number: M021
smart way MINT cavity protectionSODIUM MONOFLUOROPHOSPHATEThe Kroger Co.45cc7a60-b4a7-4263-a114-f0d1f98a87fc2025-03-19WarningsExact identifier
application number: M021
Crayola ANTICAVITY WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.720f6344-ac48-414c-a1c2-f56c3206343c2025-03-19WarningsExact identifier
application number: M021
Crayola ANTICAVITY STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios, Inc.17bd65a8-0a33-4421-8b9a-a7f9b94fe9872025-03-19WarningsExact identifier
application number: M021
HismileMAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd309366f8-6a52-fe9f-e063-6394a90a5de32025-03-18WarningsExact identifier
application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2025-03-13WarningsExact identifier
application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b92ff92-3722-3702-e063-6394a90a38b02025-03-13WarningsExact identifier
application number: M021
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2ba2318e-7a58-7b68-e063-6394a90ae7842025-03-13WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint Anticavity FluorideSODIUM FLUORIDEKenvue Brands LLCed15e0b9-00c9-0df1-e053-2a95a90a42c02025-02-28WarningsExact identifier
application number: M021
WHITE GLO BIO-ENZYMESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCf894a841-0df7-470d-8fc2-c9d6ba0edf992025-02-26WarningsExact identifier
application number: M021
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN476f453b-9215-0a11-e063-6294a90a5cd41
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD476f453b-9215-0a11-e063-6294a90a5cd41
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY476f453b-9215-0a11-e063-6294a90a5cd41
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY476f453b-9215-0a11-e063-6294a90a5cd41
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY476f453b-9215-0a11-e063-6294a90a5cd41
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY476f453b-9215-0a11-e063-6294a90a5cd41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77782-005-20777820005202 BOTTLE in 1 BOX (77782-005-20) / 99 g in 1 BOTTLE2 bottle2026-01-02NoNoCurrent