FDA.reportPublic FDA data

Calcarea Carbonica 200C

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:23

Label at a glance#

ProductCalcarea Carbonica 200C
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (HPUS*): Calcarea Carbonica 200C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves swollen tonsils and/or stitching pain on swallowing.**

OTC - PURPOSE SECTION

USES: Temporarily relieves swollen tonsils and/or stitching pain on swallowing.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Purified Water, Ethyl Alcohol USP.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the component in this product is officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0257-1

Calcarea Carbonica 200C

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0257-12023-01-10C16284748780-1ba0f9c33-1bfb-a910-e053-dadaa90a0b85Calcarea Carbonica 200C
43406-0257-12021-01-29C16284748780-1ba0f9c33-1bfb-a910-e053-dadaa90a0b85Calcarea Carbonica 200C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0257-1Calcarea Carbonica 200C30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0257CALCAREA CARBONICA 200C (CALCAREA CARBONICA) LIQUID [NATURAL CREATIONS, INC]2Current NDC, Legacy NDC, 1 package rows20230111_1ac484a5-600d-4a96-b7c5-f967a3d20fab.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
43406-025743406-0257-1

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
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 Carbonica 200CCALCAREA CARBONICANatural Creations, Inc1ac484a5-600d-4a96-b7c5-f967a3d20fab2022-12-19WarningsExact identifier
ndc (package): 43406-0257-1
ndc (product): 43406-0257
ndc11 (package): 43406025701
spl id: a1af0c99-3e2a-4e1e-8a5f-70d90ba249e6
spl set id: 1ac484a5-600d-4a96-b7c5-f967a3d20fab

Reported adverse events (FAERS/openFDA)#

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