FDA.reportPublic FDA data

ABC

Manufacturer
MARCO PHARMA INTERNATIONAL LLC | NESTMANN PHARMA
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:36:42

Label at a glance#

ProductABC
Active ingredientACONITUM NAPELLUS, MATRICARIA RECUTITA, BELLADONNA LEAF
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACONITUM NAPELLUS 3X HPUS

CHAMOMILLA 3X HPUS

BELLADONA 3X HPUS

INACTIVE INGREDIENT SECTION

ETHYL ALCOHOL (20% BY VOL) AND WATER

OTC - PURPOSE SECTION

FOR TEMPORARY RELIEF OF COLD AND FLU SYMPTOMS WITH TEMPERATURE

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

WARNINGS

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST-FEEDING, CONSULT A HEALTH PROFESSIONAL BEFORE USE

WARNINGS

WARNINGS SECTION

IF SYMPTOMS PERSIST MORE THAN A FEW DAYS, CONTACT LICENSED PRACTIONER.

INDICATIONS & USAGE SECTION

FOR TEMPORARY RELIEF OF EARACHE

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN: DAY 1; TAKE 5 DROPS ON THE TONGUE EVERY 15 MINUTES FOR 2 HOURS. THEN TAKE 5 DROPS ONCE EVERY HOUR. DAY 2; TAKE 5 DROPS ONCE EVERY HOUR. DAY 3; TAKE 5 DROPS EVERY TWO HOURS. CONTINUE WITH 10 DROPS THREE TIMES DAILY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ABC_M10032ABC_M10032

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-2035-52021-06-22C16284748780-19d75b9d0-2d1c-f424-e053-dadaa90a57ceABC
60986-2035-52020-01-31C16284748780-19d75b9d0-2d1c-f424-e053-dadaa90a57ceABC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-2035-3ABC50 mL in 1 BOTTLE, DROPPERLIQUID505
60986-2035-5ABC20 mL in 1 BOTTLELIQUID205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
BELLADONNA LEAFACTIVE INGREDIENT6GZW20TIOI1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
BELLADONNA LEAFACTIVE MOIETY6GZW20TIOI1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-203560986-2035-5, 60986-2035-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
BELLADONNA LEAF6GZW20TIOIACTIB

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 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABCACONITUM NAPELLUS, BELLADONNA, CHAMOMILLAMARCO PHARMA INTERNATIONAL LLC44749e04-ca70-410d-a754-8befe8da11e72026-01-12WarningsExact identifier
ndc (package): 60986-2035-5
ndc (package): 60986-2035-3
ndc (product): 60986-2035
ndc11 (package): 60986203503
ndc11 (package): 60986203505
spl id: 483b7f10-381e-7b69-e063-6394a90a621f
spl set id: 44749e04-ca70-410d-a754-8befe8da11e7

Reported adverse events (FAERS/openFDA)#

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