Calcarea Fluorica

Product NDC
53645-1700
11-digit product format
536451700
Labeler code
53645
Product ID
53645-1700_ba268015-4fa0-d2ae-e053-2a95a90af606
Type
HUMAN OTC DRUG
Nonproprietary name
Calcarea Fluorica
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-10-07
Substance
CALCIUM FLUORIDE
Active strength
6 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcarea Fluorica
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE6 [hp_X]/23g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3B55K4YKI

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1700-22021-01-31C16284748780-1ba0f9c33-5441-a910-e053-dadaa90a0b85Calcarea Fluorica 6x
53645-1700-22021-01-29C16284748780-1ba0f9c33-5441-a910-e053-dadaa90a0b85Calcarea Fluorica 6x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1700-2Calcarea Fluorica23 g in 1 BOTTLEGLOBULE233

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKICALCAREA FLUORICA GLOBULE [TRUE BOTANICA, LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCALCAREA FLUORICA GLOBULE [TRUE BOTANICA, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CALCAREA FLUORICA GLOBULE [TRUE BOTANICA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1700CALCAREA FLUORICA GLOBULE [TRUE BOTANICA, LLC]3Current NDC, Legacy NDC, 1 package rows20210131_9fad6631-3cfa-4c42-b684-043094bac9d4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1700-25364517000223 g in 1 BOTTLE (53645-1700-2) 23 g2013-10-070000-00-00NoNoCurrent