Label: EAR DISCOMFORT (aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla- pratensis, verbascum thapsus liquid

  • NDC Code(s): 50845-0259-1
  • Packager: Liddell Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 25, 2022

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  • ACTIVE INGREDIENTS:

    (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:

    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:

    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:

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

  • DIRECTIONS:

    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:

    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:

    Organic alcohol 20% v/v, Purified water.

  • QUESTIONS:

    DIST. BY LIDDELL LABORATORIES INC.

    WOODBINE, IA 51579

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

  • PACKAGE LABEL DISPLAY:

    ORAL SPRAYS

    LIDDELL LABORATORIES

    EST. 1994

    26 Erd
    Ear Discomfort

    HOMEOPATHIC

    1.0 FL. OZ. (30ml)

    Ear Discomfort

  • INGREDIENTS AND APPEARANCE
    EAR DISCOMFORT 
    aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla (pratensis), verbascum thapsus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50845-0259
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS200 [hp_C]  in 1 mL
    BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT200 [hp_C]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_C]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA200 [hp_C]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
    DYSPHANIA AMBROSIOIDES WHOLE (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES WHOLE15 [hp_X]  in 1 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN6 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM200 [hp_C]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS30 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50845-0259-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/202001/02/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/09/202001/02/2025
    Labeler - Liddell Laboratories, Inc. (832264241)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50845-0259) , api manufacture(50845-0259) , label(50845-0259) , pack(50845-0259)
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