FDA.reportPublic FDA data

LYCOPUS

Manufacturer
Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:36:47

Label at a glance#

ProductLYCOPUS
Active ingredientLYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, LOPHOPHYTUM LEANDRII, QUININE ARSENITE, TRIBASIC CALCIUM PHOSPHATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Bugleweed 1X HPUS

Sponge 1X HPUS

Stone Blossom 6X HPUS

Quinine 6X HPUS

Tribasic calcium phosphate 8X HPUS

Magnesium hydrogen phosphate 8X HPUS

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 thyroid conditions: hyperthyroid with palpitations.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Dosage

INDICATIONS & USAGE SECTION

Adults take 5 drops on the tongue or in 1 tablespoon water 3 times daily, increasing by one drop daily until reaction level is reached. Maxixum amount: 20 drops three times daily. Children receive 1/2 or less of the adult amount.

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

Ethyl Alcohol (53% by vol.) and Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N19_60986-1030-4N19_60986-1030-4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1030-32020-12-04C16284748780-19d75b9d0-695e-f424-e053-dadaa90a57ceDrug Facts
60986-1030-42020-12-04C16284748780-19d75b9d0-695e-f424-e053-dadaa90a57ceDrug Facts
60986-1030-32020-01-31C16284748780-19d75b9d0-695e-f424-e053-dadaa90a57ceDrug Facts
60986-1030-42020-01-31C16284748780-19d75b9d0-695e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1030-3LYCOPUS50 mL in 1 BOTTLE, GLASSLIQUID506
60986-1030-4LYCOPUS100 mL in 1 PACKAGELIQUID1006

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-103060986-1030-3, 60986-1030-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
LOPHOPHYTUM LEANDRII59150S2EOGACTIB
QUININE ARSENITE42QO5P0NLMACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB

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
LYCOPUSLYCOPUS VIRGINICUS, SPONGIA TOSTA, LOPHOPHYTUM LEANDRII, CHININUM ARSENICOSUM, CALCAREA PHOSPHORICA, MAGNESIA PHOSPHORICAMarco Pharma International LLC.f60712dc-d6ba-4773-87c5-2f4207c72a942026-01-12WarningsExact identifier
ndc (package): 60986-1030-4
ndc (package): 60986-1030-3
ndc (product): 60986-1030
ndc11 (package): 60986103004
ndc11 (package): 60986103003
spl id: 483b6b85-4d33-7a4d-e063-6394a90a5768
spl set id: f60712dc-d6ba-4773-87c5-2f4207c72a94

Reported adverse events (FAERS/openFDA)#

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