FDA.reportPublic FDA data

CALCAREA FLUORICA 6X

Product NDC
62106-1050
11-digit product format
621061050
Labeler code
62106
Product ID
62106-1050_c71e44d6-d66c-6234-e053-2995a90af97c
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Fluoride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-02-10
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
CALCAREA FLUORICA 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
0ebdb790-3ec2-3f4b-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1050-2CALCAREA FLUORICA 6X1 in 1 BOXTABLET15
62106-1050-2CALCAREA FLUORICA 6X100 in 1 BOTTLE, GLASSTABLET1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKICALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1050CALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20210715_0ebdb790-3ec2-3f4b-e054-00144ff8d46c.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 FLUORICA 6XCALCIUM FLUORIDESeroyal USA0ebdb790-3ec2-3f4b-e054-00144ff8d46c2021-07-14WarningsExact identifier
ndc (product): 62106-1050

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-1050-2621061050021 BOTTLE, GLASS in 1 BOX (62106-1050-2) / 100 TABLET in 1 BOTTLE, GLASS2015-10-020000-00-00NoNoCurrent