FDA.reportPublic FDA data

CALC FLUOR

Manufacturer
Hyland's Inc.
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:44

Label at a glance#

ProductCALC FLUOR
Active ingredientCALCIUM FLUORIDE
Label structure8 sections

Indications and uses

■Temporarily relieves: ■ cold symptoms ■ chapped or cracked skin ■ itching or pain due to hemorrhoids

Dosage and administration

■ Use as directed. ■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves cold symptoms, chapped or cracked skin, itching or pain due to hemorrhoids

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Calcarea Fluorica 6X HPUScold symptoms, hemorrhoids, chapped and cracked skin

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■Temporarily relieves:
■ cold symptoms ■ chapped or cracked skin
■ itching or pain due to hemorrhoids

Warnings

WARNINGS SECTION

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be
a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ bleeding occurs. ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops.

■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.
■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

PACKAGE LABEL - 2 x 50 COUNT BOTTLES CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS ™

CELL SALT

# 1

CALC FLUOR 6X

Cold Symptoms*

Hemorrhoids*

Chapped Skin*

2 x 50 CT BOTTLES

QUICK-DISSOLVING SINGLE TABLET DOSES

HOMEOPATHIC

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4072CALC FLUOR (CALCIUM FLUORIDE) TABLET [HYLAND'S INC.]2Legacy NDC20221202_d3373d86-6b09-fa52-e053-2a95a90a591e.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-407254973-4072-1, 54973-4072-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
41b2dc10-a8c3-fb7b-e063-6294a90add1ad3373d86-6b09-fa52-e053-2a95a90a591e2025-10-21WarningsExact identifier
spl set id: d3373d86-6b09-fa52-e053-2a95a90a591e

Reported adverse events (FAERS/openFDA)#

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