NDC 64616-050

Pediatric Earache Remedy

Ear Drops

Pediatric Earache Remedy is a Auricular (otic) Liquid in the Human Otc Drug category. It is labeled and distributed by Vitality Works, Inc. The primary component is Aconitum Napellus; Atropa Belladonna; Potassium Chloride; Plantago Major; Matricaria Recutita; Verbascum Thapsus.

Product ID64616-050_7cae238d-8a73-b18e-e053-2991aa0abdda
NDC64616-050
Product TypeHuman Otc Drug
Proprietary NamePediatric Earache Remedy
Generic NameEar Drops
Dosage FormLiquid
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2006-10-23
Marketing CategoryUNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
Labeler NameVitality Works, Inc
Substance NameACONITUM NAPELLUS; ATROPA BELLADONNA; POTASSIUM CHLORIDE; PLANTAGO MAJOR; MATRICARIA RECUTITA; VERBASCUM THAPSUS
Active Ingredient Strength6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64616-050-02

1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) > 15 mL in 1 BOTTLE, DROPPER (64616-050-01)
Marketing Start Date2007-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64616-050-01 [64616005001]

Pediatric Earache Remedy LIQUID
Marketing Categoryunapproved homeopathic
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-10-23

NDC 64616-050-02 [64616005002]

Pediatric Earache Remedy LIQUID
Marketing Categoryunapproved homeopathic
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-07-30

Drug Details

Active Ingredients

IngredientStrength
ACONITUM NAPELLUS6 [hp_X]/mL

OpenFDA Data

SPL SET ID:5769ce2c-d2e1-4069-92cc-e38bee668daf
Manufacturer
UNII
UPC Code
  • 0019277000569
  • NDC Crossover Matching brand name "Pediatric Earache Remedy" or generic name "Ear Drops"

    NDCBrand NameGeneric Name
    64616-050Pediatric Earache RemedyEar Drops
    64616-045Earache RemedyEar Drops

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