CALCAREA FLUORICA 6X

Manufacturer: Seroyal USA | SAN'UP
Effective date: 2021-07-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 02:14:40

Label at a glance#

ProductCALCAREA FLUORICA 6X

Active ingredientCALCIUM FLUORIDE

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Calcarea fluorica (Calcium fluoride) 6X

OTC - PURPOSE SECTION

Uses

For the temporary relief of symptoms associated

with cracking of joints and minor joint pain.

WARNINGS SECTION

Warnings

Do not use if you ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a healthcare practitioner before use.
Keep out of reach of children.

In case of overdose, get medical help or contact
a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare practitioner before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact

a Poison Control Center right away.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if symptoms persist or worsen.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Lactose monohydrate (milk),

magnesium stearate,

sodium carboxymethylcellulose,

xylitol

DOSAGE & ADMINISTRATION SECTION

Directions

Tip bottle slightly allowing for tablets to fall into the cap.

Use cap to drop tablets into mouth and allow them to dissolve under the tongue.

Adults and adolescents (12 years and older)

Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.

Children (under 12 years)

Take under the direction of your healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of symptoms associated

with cracking of joints and minor joint pain.

Directions

Tip bottle slightly allowing for tablets to fall into the cap.
Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to
four times daily, or as recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your healthcare practitioner.

OTHER SAFETY INFORMATION

Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.

Contents may not fill package in order
to accommodate required labeling.
Please rely on stated quantity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62016-1050-2

NDC 62016-1050-2

UNDA

tissue salt

CALCAREA FLUORICA 6X

Homeopathic Preparation

Cell Salt

For the temporary relief of symptoms associated

with cracking of joints and minor joint pain.

100 Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62106-1050-2	CALCAREA FLUORICA 6X	1 in 1 BOX	TABLET	1		5
62106-1050-2	CALCAREA FLUORICA 6X	100 in 1 BOTTLE, GLASS	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62106-1050	CALCAREA FLUORICA 6X (CALCIUM FLUORIDE) TABLET [SEROYAL USA]	5	Current NDC, Legacy NDC, 2 package rows	20210715_0ebdb790-3ec2-3f4b-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALCIUM FLUORIDE	ACTIVE INGREDIENT	O3B55K4YKI	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

CALCAREA FLUORICA 6X
Calcium Fluoride
CARBOXYMETHYLCELLULOSE SODIUM
MAGNESIUM STEARATE
FLUORIDE ION
LACTOSE MONOHYDRATE
XYLITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62106-1050	62106-1050-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CALCIUM FLUORIDE	O3B55K4YKI	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
XYLITOL	VCQ006KQ1E	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / SUBLINGUAL		505 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii+route 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / BUCCAL	4 mg		Exact identifier — unii+dosage form 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / BUCCAL	4 mg		Exact identifier — unii+dosage form 4 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii+route 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii+dosage form 4 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / SUBLINGUAL		505 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii+dosage form 4 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii+dosage form 4 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCAREA FLUORICA 6X	CALCIUM FLUORIDE	Seroyal USA	0ebdb790-3ec2-3f4b-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier ndc (package): 62106-1050-2 ndc (product): 62106-1050 ndc11 (package): 62106105002 spl id: c71e44d6-d66c-6234-e053-2995a90af97c spl set id: 0ebdb790-3ec2-3f4b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.