Home NDC 64616-050-02 Pediatric Earache Remedy
Product NDC 64616-050
Requested package NDC 64616-050-02
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 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