CALCAREA FLUORICA

Manufacturer: SEVENE USA
Effective date: 2025-02-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:32:06

Label at a glance#

ProductCALCAREA FLUORICA 6X

Active ingredientCALCIUM FLUORIDE

Label structure11 sections

Indications and uses

Minor joint pain, sprains, cracked / rough skin*.

Dosage and administration

(Adults/Children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

CALCAREA FLUORICA 6X**

**C, K, CK & X are homeopathic dilutions.

TRADITIONALLY USED FOR TEMPORARY RELIEF FROM:

OTC - PURPOSE SECTION

Minor joint pain, sprains, cracked / rough skin*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(Adults/Children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

USES:

INDICATIONS & USAGE SECTION

Minor joint pain, sprains, cracked / rough skin*.

WARNINGS

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
In case of overdose, get medical help.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.
Do not use if tamper-evidence seal is broken.
Organic verified by Alpes Control 2021/A03M216K/1.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

ORGANIC SUCROSE

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Email us at: info@ollois.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Calcarea Fluorica_6X_80ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76472-4088-1	2025-02-11	C162847	48780-1	2cef2736-a2ec-d83d-e063-dadaa90ab31f	SEVENE USA (as PLD) - CALCAREA FLUORICA 6X (76472-4088)
76472-4088-1	2025-01-30	C162847	48780-1	2cef2736-a2ec-d83d-e063-dadaa90ab31f	SEVENE USA (as PLD) - CALCAREA FLUORICA 6X (76472-4088)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76472-4088-1	CALCAREA FLUORICA6X	80 in 1 CYLINDER	PELLET	80		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76472-4088	CALCAREA FLUORICA 6X (CALCAREA FLUORICA) PELLET [SEVENE USA]	4	Current NDC, 1 package rows	20250213_ff0e811b-a880-1172-e053-6394a90a01d9.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

CALCAREA FLUORICA 6X
CALCAREA FLUORICA
SUCROSE
CALCIUM FLUORIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76472-4088	76472-4088-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
CALCIUM FLUORIDE	O3B55K4YKI	ACTIB

Source Document#

Source XML

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	CALCAREA FLUORICA	SEVENE USA	ff0e811b-a880-1172-e053-6394a90a01d9	2025-02-11	Warnings	Exact identifier ndc (package): 76472-4088-1 ndc (product): 76472-4088 ndc11 (package): 76472408801 spl id: 2ddc29a1-0636-2e52-e063-6294a90a6428 spl set id: ff0e811b-a880-1172-e053-6394a90a01d9

Reported adverse events (FAERS/openFDA)#

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