FDA.reportPublic FDA data

CALC FLUOR 6X

Product NDC
54973-4087
Requested package NDC
54973-4087-1
11-digit product format
549734087
Labeler code
54973
Product ID
54973-4087_326ffd10-9291-e8ac-e063-6394a90a69f8
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM FLUORIDE
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-12-06
Substance
CALCIUM FLUORIDE
Active strength
6 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CALC FLUOR 6X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE6 [hp_X]/1

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
dbed54cc-12ec-0a73-e053-2a95a90a8cc2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4087-1CALC FLUOR 6X100 in 1 BOTTLE, PLASTICTABLET, SOLUBLE1004
54973-4087-1CALC FLUOR 6X1 in 1 CARTONTABLET, SOLUBLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4087CALC FLUOR 6X (CALCIUM FLUORIDE) TABLET, SOLUBLE [HYLAND'S INC.]4Current NDC, Legacy NDC, 2 package rows20250411_dbed54cc-12ec-0a73-e053-2a95a90a8cc2.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
CALC FLUOR 6XCALCIUM FLUORIDEHyland's Inc.dbed54cc-12ec-0a73-e053-2a95a90a8cc22025-04-10WarningsExact identifier
ndc (package): 54973-4087-1
ndc (product): 54973-4087
ndc11 (package): 54973408701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-4087-1549734087011 BOTTLE, PLASTIC in 1 CARTON (54973-4087-1) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC2021-12-060000-00-00NoNoCurrent