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 33 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB HEBuddyFLUORIDEHEBa6af1baf-17bf-428c-8744-1490359b0cfb2025-11-13WarningsExact identifier
application number: M021
Spearmint Whitening with Hemp OilSODIUM MONOFLUOROPHOSPHATEWhole Foodsa4714db7-abc4-1eff-e053-2995a90a77402025-11-13WarningsExact identifier
application number: M021
Complete Protection TPSTANNOUS FLUORIDERite Aidccad28b5-254e-679f-e053-2a95a90abdd52025-11-13WarningsExact identifier
application number: M021
Rite Aid Sensitivity and GumSTANNOUS FLUORIDERite Aided362e9c-2dab-1102-e053-2a95a90a76f32025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEMeijer, Inc.0338495b-08a5-047f-e063-6394a90aa1242025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDECVSb673f6cc-ae70-7161-e053-2a95a90af8cd2025-11-13WarningsExact identifier
application number: M021
CVS Sens WhtngSTANNOUS FLUORIDECVScba7a512-03bc-8ebc-e053-2995a90ae12b2025-11-13WarningsExact identifier
application number: M021
Equate Repair and ProtectSTANNOUS FLUORIDEWalmartc4807b2b-7ea9-cc28-e053-2995a90a348e2025-11-13WarningsExact identifier
application number: M021
Kids Strawberry FTPSODIUM MONOFLUOROPHOSPHATETarget253c7c90-5d82-b1e0-e063-6394a90a7a4b2025-11-13WarningsExact identifier
application number: M021
Sensitivity and GumSTANNOUS FLUORIDEDG Health (Rexall)039c6e46-f995-c744-e063-6294a90a537e2025-11-13WarningsExact identifier
application number: M021
Equate Optimal Care TP Equate Optimal Care TPSTANNOUS FLUORIDEWalmart Inc.1e65b83e-a51a-4adb-e063-6394a90a06b42025-11-13WarningsExact identifier
application number: M021
Sensitive Whitening AnticavitySTANNOUS FLOURIDETopco96384c9d-cb42-7654-e053-2995a90aac082025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDERite Aidccad4383-4479-6175-e053-2a95a90a13a22025-11-13WarningsExact identifier
application number: M021
Restore and Defend Whitening TPSTANNOUS FLUORIDEKroger253ba5c0-f2ef-46e6-e063-6394a90ad9d52025-11-13WarningsExact identifier
application number: M021
Dr Tichenors With Extra Whitening and Tartar ControlSODIUM FLUORIDEDr. G. H. Tichenor's Antiseptic Companybce596e8-07eb-4e56-9007-9d283e14372d2025-11-12WarningsExact identifier
application number: M021
Kids Silly Strawberry TPSODIUM MONOFLUOROPHOSPHATEHEBab361305-01f9-7379-e053-2995a90a97b42025-11-12WarningsExact identifier
application number: M021
Care One Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEFoodhold U.S.A.81a380eb-8605-b280-e053-2a91aa0abd4b2025-11-12WarningsExact identifier
application number: M021
365 Everyday Value Kids FlourideSODIUM MONOFLUOROPHOSPHATEWhole Foods Market, Inc.836f2df8-00b6-ff2d-e053-2991aa0a89582025-11-12WarningsExact identifier
application number: M021
CVS Rapid Protection SensitiveSTANNOUS FLUORIDECVS Pharmacy8162fcc0-7a24-678c-e053-2a91aa0af2fe2025-11-12WarningsExact identifier
application number: M021
Rite Aid Sensitive Rapid ProtectionSTANNOUS FLUORIDERite Aid8335dd4d-62a0-6861-e053-2a91aa0a82832025-11-12WarningsExact 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