FDA.reportPublic FDA data

CACTUS

Manufacturer
Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date
2024-12-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:29:19

Label at a glance#

ProductCACTUS
Active ingredientCAMPHOR (NATURAL), KALMIA LATIFOLIA LEAF, SPIGELIA ANTHELMIA, LACHESIS MUTA VENOM, ARNICA MONTANA, TOBACCO LEAF, NITROGLYCERIN, SELENICEREUS GRANDIFLORUS STEM, CONVALLARIA MAJALIS, CRATAEGUS LAEVIGATA WHOLE
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Midland Hathorne 1XHPUS

Night Blooming Cerus 2XHPUS

Lily of the Valley 3XHPUS

Natural Camphor 2XHPUS

Mountain laurel 4XHPUS

Pinkroot 4XHPUS

Bushmaster viper 8XHPUS

Mountain Arnica 6XHPUS

Tabacco 8XHPUS

Nitroglycerin 8XHPUS

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 RELIEF OF CHEST PAIN DUE TO STRESS; ANGINA PECTORIS; MYOCARDIAL INSUFFICIENCY; TOBACCO ABUSE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Dosage

INDICATIONS & USAGE SECTION

Adults take 30 drops in 1 oz water three times daily. For acute symptoms, take 40 drops four to five times daily. Children receive 10 drops in 1 oz tepid water three time daily.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

(Read Suggested Use Section)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CONTAINS E thyl Alcohol (51.5% by vol.) and Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N16_60986-1028-4N16_60986-1028-4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1028-32026-01-29C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts
60986-1028-42026-01-29C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts
60986-1028-32020-12-04C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts
60986-1028-42020-12-04C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts
60986-1028-32020-01-31C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts
60986-1028-42020-01-31C16284748780-19d75b9d0-9613-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1028-3CACTUS50 mL in 1 BOTTLE, GLASSLIQUID506
60986-1028-4CACTUS100 mL in 1 BOTTLE, GLASSLIQUID1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60986-1028CACTUS (CRATAEGUS LAEVIGATA, CACTUS GRANDIFLORUS, CONVALLARIA MAJALIS, CAMPHOR, KALMIA LATIFOLIA, SPIGELIA ANTHELMIA, LACHESIS MUTUS, ARNICA MONTANA, TABACUM, GLONOINUM) LIQUID [MARCO PHARMA INTERNATIONAL LLC.]6Legacy NDC, 2 package rows20241207_7daf5521-8df2-4cf2-b1f6-b46bfad63f67.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-102860986-1028-3, 60986-1028-4

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
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
KALMIA LATIFOLIA LEAF79N6542N18ACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
ARNICA MONTANAO80TY208ZWACTIB
TOBACCO LEAF6YR2608RSUACTIB
NITROGLYCERING59M7S0WS3ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
CRATAEGUS LAEVIGATA WHOLEEFX9G567MJACTIB

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
2877a8f0-ede2-7380-e063-6394a90a10277daf5521-8df2-4cf2-b1f6-b46bfad63f672024-12-04WarningsExact identifier
spl id: 2877a8f0-ede2-7380-e063-6394a90a1027
spl set id: 7daf5521-8df2-4cf2-b1f6-b46bfad63f67

Reported adverse events (FAERS/openFDA)#

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