FDA.reportPublic FDA data

Pulsatilla 200C

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:28

Label at a glance#

ProductPulsatilla 200C
Active ingredientPULSATILLA VULGARIS WHOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Pulsatilla 200C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves moodiness, weepiness, &/or fear of abandoment.**

OTC - PURPOSE SECTION

USES: Temporarily relieves moodiness, weepiness, &/or fear of abandoment.**

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: 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 components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0258-1

Pulsatilla 200C

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0258-1Pulsatilla 200C30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0258PULSATILLA 200C (PULSATILLA) LIQUID [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20230111_9c403208-8eaa-4ead-aab6-563b56a8bf48.zip

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
43406-025843406-0258-1

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
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
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
Pulsatilla 200CPULSATILLANatural Creations, Inc9c403208-8eaa-4ead-aab6-563b56a8bf482018-12-21WarningsExact identifier
ndc (package): 43406-0258-1
ndc (product): 43406-0258
ndc11 (package): 43406025801
spl id: 66443525-1188-408b-a372-3427e59245fd
spl set id: 9c403208-8eaa-4ead-aab6-563b56a8bf48

Reported adverse events (FAERS/openFDA)#

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