FDA.reportPublic FDA data

Calcarea Sulphurica

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:32:00

Label at a glance#

ProductCalcarea Sulphurica 200ck
Active ingredientCALCIUM SULFATE ANHYDROUS
Label structure13 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

active ingredient:

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS Calcarea Sulphurica 200ck **C, K, CK, AND X ARE HOMEOPATHIC DILUTIONS

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Acne* - Abscesses*

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE:

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS:

WARNINGS SECTION

Stop use and ask a physician 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.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

SUCROSE.

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

USE:

RECENT MAJOR CHANGES SECTION

Condition listed above or as directed by a physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALCAREA_SULPH 200CKCALCAREA_SULPH 200CKCALCAREA_SULPH 200CKCALCAREA_SULPH 200CKCALCAREA_SULPH 200CKCALCAREA_SULPH 200CK

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
76472-3009-12025-02-11C16284748780-12cef2736-a246-d83d-e063-dadaa90ab31fSevene USA (as PLD) - CALCAREA SULPHURICA 200ck (76472-3009)
76472-3009-12025-01-30C16284748780-12cef2736-a246-d83d-e063-dadaa90ab31fSevene USA (as PLD) - CALCAREA SULPHURICA 200ck (76472-3009)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-3009-1Calcarea Sulphurica200ck80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-3009CALCAREA SULPHURICA 200CK (CALCIUM SULFATE ANHYDROUS) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250213_c8d51479-1fe1-68d5-e053-2995a90aae72.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-300976472-3009-1

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
NameUNIIKind
SUCROSEC151H8M554IACT
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB

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
Calcarea Sulphurica 200ckCALCIUM SULFATE ANHYDROUSSEVENE USAc8d51479-1fe1-68d5-e053-2995a90aae722025-02-11WarningsExact identifier
ndc (package): 76472-3009-1
ndc (product): 76472-3009
ndc11 (package): 76472300901
spl id: 2ddc269b-5442-d6b3-e063-6394a90a5f0a
spl set id: c8d51479-1fe1-68d5-e053-2995a90aae72

Reported adverse events (FAERS/openFDA)#

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