FDA.reportPublic FDA data

Arsenicum Album 200C

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:16:51

Label at a glance#

ProductArsenicum Album 200C
Active ingredientARSENIC TRIOXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (HPUS*): Arsenicum Album 200C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves upset stomach, nausea, and diarrhea from food poisoning.**

OTC - PURPOSE SECTION

USES: Temporarily relieves upset stomach, nausea, and diarrhea from food poisoning.**

DOSAGE & ADMINISTRATION SECTION

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

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: Ethyl Alcohol USP, Purified Water.

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

43406-0318-1

ARSENICUM ALBUM 200C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0318-12022-02-17C16284748780-1d6a99b39-375e-a426-e053-dadaa90af4c2ARSENICUM ALBUM 200C
43406-0318-12022-01-28C16284748780-1d6a99b39-375e-a426-e053-dadaa90af4c2ARSENICUM ALBUM 200C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0318-1Arsenicum Album 200C30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0318ARSENICUM ALBUM 200C (ARSENIC TRIOXIDE) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20220218_e08c2531-cb00-4016-a2a8-f6c88f0e306c.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
43406-031843406-0318-1

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
ARSENIC TRIOXIDES7V92P67HOACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
Arsenicum Album 200CARSENIC TRIOXIDENatural Creations, Inc.e08c2531-cb00-4016-a2a8-f6c88f0e306c2022-02-17WarningsExact identifier
ndc (package): 43406-0318-1
ndc (product): 43406-0318
ndc11 (package): 43406031801
spl id: 1faad233-11fd-43af-b57e-4123165b8dfd
spl set id: e08c2531-cb00-4016-a2a8-f6c88f0e306c

Reported adverse events (FAERS/openFDA)#

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