Sodium Monofluorophosphate

Product NDC
67777-181
11-digit product format
677770181
Labeler code
67777
Product ID
67777-181_1c58c582-92e0-4533-e063-6394a90a9fe5
Type
HUMAN OTC DRUG
Nonproprietary name
White Toothpaste
Dosage form
PASTE
Route
DENTAL
Labeler
Dynarex Corporation
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-16
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
760 mg/g
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
Sodium Monofluorophosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE760 mg/g

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
1be422b9-6320-ed5c-e063-6294a90a7e42Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-181-01Sodium Monofluorophosphate42.5 g in 1 TUBEPASTE42.52
67777-181-02Sodium Monofluorophosphate144 in 1 CASEPASTE1442
67777-181-03Sodium Monofluorophosphate78 g in 1 TUBEPASTE782
67777-181-04Sodium Monofluorophosphate144 in 1 CASEPASTE1442
67777-181-05Sodium Monofluorophosphate130 g in 1 TUBEPASTE1302
67777-181-06Sodium Monofluorophosphate1 in 1 BOXPASTE12
67777-181-07Sodium Monofluorophosphate60 in 1 CASEPASTE602
67777-181-08Sodium Monofluorophosphate24 g in 1 TUBEPASTE242
67777-181-09Sodium Monofluorophosphate144 in 1 BOXPASTE1442
67777-181-10Sodium Monofluorophosphate720 in 1 CASEPASTE7202
67777-181-11Sodium Monofluorophosphate17 g in 1 TUBEPASTE172
67777-181-12Sodium Monofluorophosphate144 in 1 BOXPASTE1442
67777-181-13Sodium Monofluorophosphate720 in 1 CASEPASTE7202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-181SODIUM MONOFLUOROPHOSPHATE (WHITE TOOTHPASTE) PASTE [DYNAREX CORPORATION]2Current NDC, 13 package rows20240716_1be422b9-6320-ed5c-e063-6294a90a7e42.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 37 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Ipana Wintergreen FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Inc.5776cc3e-4fd1-4bd7-8d82-f82508e6b8d02025-07-28WarningsExact identifier
application number: M021
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
application number: M021
Dubai Chocolate FlavorANTICAVITY TOOTHPASTESuperMouth, LLC.d1615a53-ecfc-49d1-b836-f7643b9d26602025-07-24WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
application number: M021
Dubai Chocolate Fluoride MouthwashANTICAVITY MOUTHWASHSuperMouth, LLC.ef81a983-64c1-4913-9235-25451f0238522025-07-23WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.3409a749-4a1a-4950-8c21-364d1b977af72025-07-22WarningsExact identifier
application number: M021
Act Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.dc209500-2bf4-42fb-b3a1-d0fb8d63dbd82025-07-22WarningsExact identifier
application number: M021
Brush Buddies Oral Rinse Sparkle MintSODIUM FLUORIDEASHTEL STUDIOS, INCfe2c06fc-6497-4888-877f-1a88e02fad202025-07-15WarningsExact identifier
application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.1620c7fa-2af6-4462-af5d-9e122942788a2025-07-15WarningsExact identifier
application number: M021
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.13dba3ce-88a8-490c-a906-cfd206d1d2902025-07-01WarningsExact identifier
application number: M021
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINTSODIUM FLUORIDEAshtel Studios, Inc.baae4f4a-54ef-472a-9c94-31703435750b2025-07-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1be422b9-6320-ed5c-e063-6294a90a7e422
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1be422b9-6320-ed5c-e063-6294a90a7e422
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1be422b9-6320-ed5c-e063-6294a90a7e422
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1be422b9-6320-ed5c-e063-6294a90a7e422
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1be422b9-6320-ed5c-e063-6294a90a7e422
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1be422b9-6320-ed5c-e063-6294a90a7e422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-181-016777701810142.5 g in 1 TUBE42.5 gHistorical
67777-181-0267777018102144 TUBE in 1 CASE (67777-181-02) / 42.5 g in 1 TUBE (67777-181-01) 144 tube2024-07-16NoNoCurrent
67777-181-036777701810378 g in 1 TUBE78 gHistorical
67777-181-0467777018104144 TUBE in 1 CASE (67777-181-04) / 78 g in 1 TUBE (67777-181-03) 144 tube2024-07-16NoNoCurrent
67777-181-0567777018105130 g in 1 TUBE130 gHistorical
67777-181-06677770181061 in 1 BOXHistorical
67777-181-076777701810760 BOX in 1 CASE (67777-181-07) / 1 TUBE in 1 BOX (67777-181-06) / 130 g in 1 TUBE (67777-181-05) 60 box2024-07-16NoNoCurrent
67777-181-086777701810824 g in 1 TUBE24 gHistorical
67777-181-0967777018109144 in 1 BOXHistorical
67777-181-1067777018110720 BOX in 1 CASE (67777-181-10) / 144 TUBE in 1 BOX (67777-181-09) / 24 g in 1 TUBE (67777-181-08) 720 box2024-07-16NoNoCurrent
67777-181-116777701811117 g in 1 TUBE17 gHistorical
67777-181-1267777018112144 in 1 BOXHistorical
67777-181-1367777018113720 BOX in 1 CASE (67777-181-13) / 144 TUBE in 1 BOX (67777-181-12) / 17 g in 1 TUBE (67777-181-11) 720 box2024-07-16NoNoCurrent