FDA.reportPublic FDA data

Ear Discomfort

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2022-05-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:00:28

Label at a glance#

ProductEar Discomfort
Active ingredientACONITUM NAPELLUS, BACILLUS ANTHRACIS IMMUNOSERUM RABBIT, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, CAPSICUM, MATRICARIA RECUTITA, DYSPHANIA AMBROSIOIDES WHOLE, EUPHORBIA RESINIFERA RESIN, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PLANTAGO MAJOR, ANEMONE PRATENSIS, VERBASCUM THAPSUS
Label structure9 sections

Dosage and administration

Adults and children over 12: Place 15 drops under the tongue up to six times per day until symptoms are relieved. Children 12 and under: Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop) 7.14% of Aconitum Napellus 200C, Anthracinum 200C, Arnica Montana 200C, Baptisia Tinctoria 3X, Belladonna 200C, Capsicum Annuum 6X, Chamomilla 3X, Chenopodium Anthelminticum 15X, Euphorbium Officinarum 6X, Lachesis Mutus 200C, Magnesia Phosphorica 10X, Plantago Major 3X, Pulsatilla (Pratensis) 30X, Verbascum Thapsus 6X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 4 days, there is discharge from the ear, or there is a fever.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: Place 15 drops under the tongue up to six times per day until symptoms are relieved.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms of clogging: pressure, sensitivity, or discomfort of the ear.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY LIDDELL LABORATORIES INC.

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL LABORATORIES

EST. 1994

26 Erd
Ear Discomfort

HOMEOPATHIC

1.0 FL. OZ. (30ml)

Ear DiscomfortEar Discomfort

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0259-12022-05-25C16284748780-1d6a99b39-a17f-a426-e053-dadaa90af4c2Drug Facts:
50845-0259-12022-01-28C16284748780-1d6a99b39-a17f-a426-e053-dadaa90af4c2Drug Facts:

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-025950845-0259-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
ARNICA MONTANAO80TY208ZWACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAPSICUM00UK7646FGACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
DYSPHANIA AMBROSIOIDES WHOLE4H5RSU087IACTIB
EUPHORBIA RESINIFERA RESIN1TI1O9028KACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
PLANTAGO MAJORW2469WNO6UACTIB
ANEMONE PRATENSIS8E272251DIACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
d4199224-1f3c-4cdd-bf46-00b87a39baf62a516657-993a-400b-ad9e-d3af096fea802022-05-25WarningsExact identifier
spl id: d4199224-1f3c-4cdd-bf46-00b87a39baf6
spl set id: 2a516657-993a-400b-ad9e-d3af096fea80

Reported adverse events (FAERS/openFDA)#

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