Home NDC 64616-050 Pediatric Earache Remedy
Product NDC 64616-050
11-digit product format 646160050
Labeler code 64616
Product ID 64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318
Type HUMAN OTC DRUG
Nonproprietary name Ear Drops
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Vitality Works, Inc
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2006-10-23
Substance ACONITUM NAPELLUS; ATROPA BELLADONNA; MATRICARIA RECUTITA; PLANTAGO MAJOR; POTASSIUM CHLORIDE; VERBASCUM THAPSUS
Active strength 6; 3; 6; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Pediatric Earache Remedy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACONITUM NAPELLUS 6 [hp_X]/mL ATROPA BELLADONNA 3 [hp_X]/mL POTASSIUM CHLORIDE 6 [hp_X]/mL PLANTAGO MAJOR 3 [hp_X]/mL MATRICARIA RECUTITA 3 [hp_X]/mL VERBASCUM THAPSUS 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64616-050-01 Pediatric Earache Remedy 15 mL in 1 BOTTLE, DROPPER LIQUID 15 9 64616-050-02 Pediatric Earache Remedy 1 in 1 CARTON LIQUID 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACONITUM NAPELLUS ACTIVE INGREDIENT U0NQ8555JD PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 ATROPA BELLADONNA ACTIVE INGREDIENT WQZ3G9PF0H PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 MATRICARIA RECUTITA ACTIVE INGREDIENT G0R4UBI2ZZ PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 PLANTAGO MAJOR ACTIVE INGREDIENT W2469WNO6U PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 VERBASCUM THAPSUS ACTIVE INGREDIENT C9TD27U172 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 ACONITUM NAPELLUS ACTIVE MOIETY U0NQ8555JD PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 ATROPA BELLADONNA ACTIVE MOIETY WQZ3G9PF0H PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 MATRICARIA RECUTITA ACTIVE MOIETY G0R4UBI2ZZ PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 PLANTAGO MAJOR ACTIVE MOIETY W2469WNO6U PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 VERBASCUM THAPSUS ACTIVE MOIETY C9TD27U172 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 CITRUS PARADISI SEED INACTIVE INGREDIENT 12F08874Y7 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 OLEA EUROPAEA LEAF INACTIVE INGREDIENT MJ95C3OH47 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-050 PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC] 8 Current NDC, Legacy NDC, 2 package rows 20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64616-050-01 64616005001 15 mL in 1 BOTTLE, DROPPER 15 ml Historical 64616-050-02 64616005002 1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01) 2007-07-30 0000-00-00 No No Current