HYDRASTIS

Manufacturer
Marco Pharma International LLC | Nestmann Pharma GmbH
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:00

Label at a glance#

ProductHYDRASTIS
Active ingredientGOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, EPHEDRA DISTACHYA FLOWERING TWIG, DAPHNE MEZEREUM BARK, KEROSENE, PULSATILLA VULGARIS, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrastis Canadensis 4xHPUS

Lycopodium Clavatum 3xHPUS

Ephedra Vulgaris 3xHPUS

Mezereum 3xHPUS

Petroleum 8xHPUS

Pulsatilla 3xHPUS

Thuja Occidentalis 10xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

DOSAGE & ADMINISTRATION SECTION

Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

WARNINGS SECTION

Do not spray in eyes, mouth or ears.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed, get medical help or contact Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Aqua Demineralisata, Aqua Hamamelidis, Alcohol 7.7% by volume, Glycerin, Thymol, and Hydrogen Peroxide.

INDICATIONS & USAGE SECTION

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N10216N10216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1015-5HYDRASTIS20 mL in 1 BOTTLE, SPRAYSPRAY202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60986-1015HYDRASTIS (HYDRASTIS CANADENSIS, LYCOPODIUM CLAVATUM, EPHEDRA VULGARIS, MEZEREUM, PETROLEUM, PULSATILLA, THUJA OCCIDENTALIS) SPRAY [MARCO PHARMA INTERNATIONAL LLC]2Legacy NDC, 1 package rows20231207_effc3327-df1b-0c9b-e053-2a95a90a4f29.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-101560986-1015-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
0be0cc34-ec75-b6b7-e063-6294a90aadfceffc3327-df1b-0c9b-e053-2a95a90a4f292023-12-06WarningsExact identifier
spl id: 0be0cc34-ec75-b6b7-e063-6294a90aadfc
spl set id: effc3327-df1b-0c9b-e053-2a95a90a4f29

Reported adverse events (FAERS/openFDA)#

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