FDA.reportPublic FDA data

Calcarea Sulphurica

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:49:52

Label at a glance#

ProductCalcarea Sulphurica 8003
Active ingredientCALCIUM SULFATE ANHYDROUS
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Calcarea sulphurica 6X, 12X, 30X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

Use according to standard homeopathic indications for self-limiting conditions. Common Materia Medica indications: boils, bruises, cough, and dry, itching skin.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

In case of overdose, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Calcarea Sulphurica

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-8003-22026-01-09C16284748780-11030e365-67b9-111a-e063-dadaa90a10e2CELL3
63083-8003-22026-01-09C16284748780-11030e365-67b9-111a-e063-dadaa90a10e2CELL3
63083-8003-22024-01-30C16284748780-11030e365-67b9-111a-e063-dadaa90a10e2CELL3
63083-8003-22024-01-30C16284748780-11030e365-67b9-111a-e063-dadaa90a10e2CELL3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-8003-2Calcarea Sulphurica800359 mL in 1 BOTTLE, DROPPERLIQUID592

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-800363083-8003-2

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
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:42

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 Sulphurica 8003CALCAREA SULPHURICAProfessional Complementary Health Formulas64ca7246-ef59-4499-9887-a8a8a4c75f8f2026-01-08WarningsExact identifier
ndc (package): 63083-8003-2
ndc (product): 63083-8003
ndc11 (package): 63083800302
spl id: 8ba2e29d-3053-4cca-a352-973705f97a2d
spl set id: 64ca7246-ef59-4499-9887-a8a8a4c75f8f

Reported adverse events (FAERS/openFDA)#

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