FDA.reportPublic FDA data

NDC 64616-050-01 - Pediatric Earache Remedy

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64616-050
Requested NDC
64616-050-01
Package NDCs from labels
64616-050-01, 64616-050-02
Manufacturer
Vitality Works, Inc | Vitality Works, Inc.
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ear Drops - Vitality Works, Inc | Vitality Works, Inc.Vitality Works, Inc | Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-050-01Pediatric Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID159
64616-050-02Pediatric Earache Remedy1 in 1 CARTONLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-050PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]8Current NDC, Legacy NDC, 2 package rows20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U172PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RPEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]1

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 13 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rhododendron Combination 9241RHODODENDRON COMBINATIONProfessional Complementary Health Formulas9a3d93c9-261d-4711-ad75-8e4c1f87c9362026-01-08WarningsExact identifier
unii: U0NQ8555JD
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: U0NQ8555JD
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Aconitum napellus 7101ACONITUM NAPELLUSProfessional Complementary Health Formulas9d04cb5d-cafa-4a64-bd6e-5724b9ee36ef2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Flex Drops 2024FLEX DROPSProfessional Complementary Health Formulase857670f-de84-494e-9e81-80144792d1fa2026-01-08WarningsExact identifier
unii: 660YQ98I10
Fever Flu Symptom Drops 2087FEVER FLU SYMPTOM DROPSProfessional Complementary Health Formulas13cfd1c2-95fe-451c-b07e-7d27ad3dfe812026-01-08WarningsExact identifier
unii: U0NQ8555JD
Glaucoma Drops 2074GLAUCOMA DROPSProfessional Complementary Health Formulas7cf2052e-15f8-4b04-ae18-1847da8f42362026-01-08WarningsExact identifier
unii: U0NQ8555JD
Flu Immune Drops 2145FLU IMMUNE DROPSProfessional Complementary Health Formulasb9cb50f7-0442-4f8a-a2e9-72b7a62c61862026-01-08WarningsExact identifier
unii: U0NQ8555JD
TMJ Drops 2154TMJ DROPSProfessional Complementary Health Formulasa937e0e7-899d-48db-af58-9e0c11d5a24c2026-01-08WarningsExact identifier
unii: C9TD27U172
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: U0NQ8555JD
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: U0NQ8555JD
Aconitum Combination 9201ACONITUM COMBINATIONProfessional Complementary Health Formulasa9704081-067e-48dd-bcfd-02eddb1cf2792026-01-08WarningsExact identifier
unii: U0NQ8555JD
Mucolytic Drainage Liquescence 3017MUCOLYTIC DRAINAGE LIQUESCENCEProfessional Complementary Health Formulasf6dd9b87-053d-4d88-b0e4-7693f5524ce72026-01-08WarningsExact identifier
unii: W2469WNO6U
Pain Formula I Drops 2089PAIN FORMULA I DROPSProfessional Complementary Health Formulasfe6aeed7-95de-4ca0-828e-61451b467c722026-01-08WarningsExact identifier
unii: U0NQ8555JD
Asthma Drops 2010ASTHMA DROPSProfessional Complementary Health Formulasb9f234ad-a5ff-40a9-bc51-c192f30140902026-01-08WarningsExact identifier
unii: U0NQ8555JD
Turskas Liquescence 3008TURSKAS LIQUESCENCEProfessional Complementary Health Formulasac81152a-6f06-48f8-bf2c-e446c70e0ef52026-01-08WarningsExact identifier
unii: U0NQ8555JD
Euphorbium Combination 9255EUPHORBIUM COMBINATIONProfessional Complementary Health Formulasff642588-439e-4e79-8c7b-3d388938eca52026-01-08WarningsExact identifier
unii: W2469WNO6U
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: U0NQ8555JD
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.