pediatric earache remedy

Generic: ear drops

Labeler: vitality works, inc
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name pediatric earache remedy
Generic Name ear drops
Labeler vitality works, inc
Dosage Form LIQUID
Routes
AURICULAR (OTIC)
Active Ingredients

aconitum napellus 6 [hp_X]/mL, atropa belladonna 3 [hp_X]/mL, matricaria recutita 6 [hp_X]/mL, plantago major 3 [hp_X]/mL, potassium chloride 3 [hp_X]/mL, verbascum thapsus 6 [hp_X]/mL

Manufacturer
Vitality Works, Inc

Identifiers & Regulatory

Product NDC 64616-050
Product ID 64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2006-10-23

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64616050
Hyphenated Format 64616-050

Supplemental Identifiers

UPC
0019277000569
UNII
U0NQ8555JD WQZ3G9PF0H G0R4UBI2ZZ W2469WNO6U 660YQ98I10 C9TD27U172

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pediatric earache remedy (source: ndc)
Generic Name ear drops (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 6 [hp_X]/mL
  • 3 [hp_X]/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01)
source: ndc

Packages (1)

64616-050-02 1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01)

Ingredients (6)

aconitum napellus (6 [hp_X]/mL) atropa belladonna (3 [hp_X]/mL) matricaria recutita (6 [hp_X]/mL) plantago major (3 [hp_X]/mL) potassium chloride (3 [hp_X]/mL) verbascum thapsus (6 [hp_X]/mL)

Linked Drug Pages (1)

Pediatric Earache Remedy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "462ed52e-9da2-6cc3-e063-6294a90ad318", "openfda": {"upc": ["0019277000569"], "unii": ["U0NQ8555JD", "WQZ3G9PF0H", "G0R4UBI2ZZ", "W2469WNO6U", "660YQ98I10", "C9TD27U172"], "spl_set_id": ["5769ce2c-d2e1-4069-92cc-e38bee668daf"], "manufacturer_name": ["Vitality Works, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (64616-050-02)  / 15 mL in 1 BOTTLE, DROPPER (64616-050-01)", "package_ndc": "64616-050-02", "marketing_start_date": "20070730"}], "brand_name": "Pediatric Earache Remedy", "product_id": "64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318", "dosage_form": "LIQUID", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]"], "product_ndc": "64616-050", "generic_name": "Ear Drops", "labeler_name": "Vitality Works, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pediatric Earache Remedy", "active_ingredients": [{"name": "ACONITUM NAPELLUS", "strength": "6 [hp_X]/mL"}, {"name": "ATROPA BELLADONNA", "strength": "3 [hp_X]/mL"}, {"name": "MATRICARIA RECUTITA", "strength": "6 [hp_X]/mL"}, {"name": "PLANTAGO MAJOR", "strength": "3 [hp_X]/mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "3 [hp_X]/mL"}, {"name": "VERBASCUM THAPSUS", "strength": "6 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20061023", "listing_expiration_date": "20261231"}