Calcarea Fluorica

Product NDC
71753-8001
11-digit product format
717538001
Labeler code
71753
Product ID
71753-8001_8f978973-3260-45f8-98bc-b98399b30aa2
Type
HUMAN OTC DRUG
Nonproprietary name
Calcarea Fluorica
Dosage form
SPRAY
Route
ORAL
Labeler
Ratis, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-09-30
Substance
CALCIUM FLUORIDE
Active strength
12 [hp_X]/mL
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 FLUORIDE12 [hp_X]/mL

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
3ccb772c-dbd4-4963-b5d8-75f1fb54f03eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71753-8001-1Calcarea Fluorica30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71753-8001CALCAREA FLUORICA SPRAY [RATIS, LLC]3Current NDC, Legacy NDC, 1 package rows20230714_3ccb772c-dbd4-4963-b5d8-75f1fb54f03e.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 FLUORICARatis, LLC3ccb772c-dbd4-4963-b5d8-75f1fb54f03e2023-07-13WarningsExact identifier
ndc (product): 71753-8001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71753-8001-17175380010130 mL in 1 BOTTLE, SPRAY (71753-8001-1) 30 ml2020-09-300000-00-00NoNoCurrent