Sodium Fluoride

Product NDC
58657-322
11-digit product format
586570322
Labeler code
58657
Product ID
58657-322_41b6cf2b-2810-7774-e063-6394a90ac1fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-08-15
Substance
SODIUM FLUORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui315102

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-322-50Sodium Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-322-50ML - Milliliter58657-322cd9e95eb-2f5f-4e30-90fd-1a467d86727812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-322SODIUM FLUORIDE SOLUTION/ DROPS [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20241126_35dcc144-130d-4ec7-a266-c084008ac70c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315102sodium fluoride 0.5 MG in 1 mL Oral SolutionPSN35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 1.1 MG/ML Oral SolutionSCD35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 0.11 % Oral DropsSY35dcc144-130d-4ec7-a266-c084008ac70c6
315102sodium fluoride 1.1 MG (fluoride ion 0.5 MG) per ML Oral DropsSY35dcc144-130d-4ec7-a266-c084008ac70c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-322-505865703225050 mL in 1 BOTTLE, DROPPER (58657-322-50) 50 ml2018-08-150000-00-00NoNoCurrent