FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O3B55K4YKIInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fad6631-3cfa-4c42-b684-043094bac9d4Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcarea FluoricaCALCAREA FLUORICATrue Botanica, LLC9fad6631-3cfa-4c42-b684-043094bac9d42021-01-30WarningsExact identifier
ndc (product): 53645-1700

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