Hydrastis

Manufacturer: Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date: 2021-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:23:31

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 structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

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 Sates.

Purpose

OTC - PURPOSE 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.

Suggested use

INDICATIONS & USAGE SECTION

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

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

(Read Suggested Use Section)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrastis_N1214

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60986-1013-3	2020-12-04	C162847	48780-1	9d75b9d0-11fb-f424-e053-dadaa90a57ce	Drug Facts
60986-1013-4	2020-12-04	C162847	48780-1	9d75b9d0-11fb-f424-e053-dadaa90a57ce	Drug Facts
60986-1013-3	2020-01-31	C162847	48780-1	9d75b9d0-11fb-f424-e053-dadaa90a57ce	Drug Facts
60986-1013-4	2020-01-31	C162847	48780-1	9d75b9d0-11fb-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DAPHNE MEZEREUM BARK	ACTIVE INGREDIENT	X2N6E405GV	1
EPHEDRA DISTACHYA FLOWERING TWIG	ACTIVE INGREDIENT	R55VQ87DP3	1
GOLDENSEAL	ACTIVE INGREDIENT	ZW3Z11D0JV	1
KEROSENE	ACTIVE INGREDIENT	1C89KKC04E	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE INGREDIENT	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
THUJA OCCIDENTALIS LEAFY TWIG	ACTIVE INGREDIENT	1NT28V9397	1
DAPHNE MEZEREUM BARK	ACTIVE MOIETY	X2N6E405GV	1
EPHEDRA DISTACHYA FLOWERING TWIG	ACTIVE MOIETY	R55VQ87DP3	1
GOLDENSEAL	ACTIVE MOIETY	ZW3Z11D0JV	1
KEROSENE	ACTIVE MOIETY	1C89KKC04E	1
LYCOPODIUM CLAVATUM SPORE	ACTIVE MOIETY	C88X29Y479	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
THUJA OCCIDENTALIS LEAFY TWIG	ACTIVE MOIETY	1NT28V9397	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HAMAMELIS VIRGINIANA TOP WATER	INACTIVE INGREDIENT	NT00Y05A2V	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Hydrastis
Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,
WATER
HAMAMELIS VIRGINIANA TOP WATER
ALCOHOL
GLYCERIN
THYMOL
GOLDENSEAL
LYCOPODIUM CLAVATUM SPORE
EPHEDRA DISTACHYA FLOWERING TWIG
DAPHNE MEZEREUM BARK
KEROSENE
PULSATILLA VULGARIS
THUJA OCCIDENTALIS LEAFY TWIG

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60986-1013	60986-1013-3, 60986-1013-4, 60986-1013-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
HAMAMELIS VIRGINIANA TOP WATER	NT00Y05A2V	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
THYMOL	3J50XA376E	IACT
GOLDENSEAL	ZW3Z11D0JV	ACTIB
LYCOPODIUM CLAVATUM SPORE	C88X29Y479	ACTIB
EPHEDRA DISTACHYA FLOWERING TWIG	R55VQ87DP3	ACTIB
DAPHNE MEZEREUM BARK	X2N6E405GV	ACTIB
KEROSENE	1C89KKC04E	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
THUJA OCCIDENTALIS LEAFY TWIG	1NT28V9397	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 136 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
THYMOL	THYMOL	3J50XA376E	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0e7705bd-15fc-d906-e063-6394a90a2ee4			6cd912eb-6f98-45c7-a81e-248bb112ab1e	2024-01-08	Warnings	Exact identifier spl set id: 6cd912eb-6f98-45c7-a81e-248bb112ab1e

Reported adverse events (FAERS/openFDA)#

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