FDA.reportPublic FDA data

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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact 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