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

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 Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

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

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