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 26 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.3f2b75d8-89f1-8d67-e063-6294a90a01662025-09-19WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
unii: G0R4UBI2ZZ
I-SleepABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANANewton Laboratories, Inc.c6f053fe-8b59-7226-e053-2995a90a80932025-09-18WarningsExact identifier
unii: WQZ3G9PF0H
unii: G0R4UBI2ZZ
Potassium ChloridePOTASSIUM CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs542e16b0-44db-490f-b44e-4c88a6e3d8b82025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEStrides Pharma Science Limited0224e5b3-3c49-4e6e-aa78-1abcc69692462025-09-17Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Camilia TummyACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, COPPER, CITRULLUS COLOCYNTHIS FRUIT PULPBoiron06c011fd-2814-2a57-e063-6394a90a80992025-09-16Exact identifier
unii: G0R4UBI2ZZ
MelissaMELISSAUriel Pharmacy, Inc3eef31ef-39a3-3813-e063-6394a90a82af2025-09-16WarningsExact identifier
unii: WQZ3G9PF0H
unii: U0NQ8555JD
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Aconitum napellusACONITUM NAPELLUSBoiron840f7e2c-d7a3-d2ac-e053-2991aa0ac04a2025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b090d3-01cc-4b6d-e053-2991aa0ab2112025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840f3ea5-a57f-34f2-e053-2991aa0aa1df2025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b23237-c6ef-3231-e053-2a91aa0aa5692025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840f4776-c8dc-655f-e053-2991aa0ad7b02025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b20bf1-846c-4a10-e053-2991aa0abefe2025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b1d915-97a1-4535-e053-2a91aa0aa4642025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron84b29e49-ea6a-8519-e053-2991aa0a7cd12025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840eea30-7779-d232-e053-2a91aa0ac5962025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron8860ffcb-a889-4deb-e053-2995a90ac0802025-09-10Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSBoiron840f0eec-a05a-7c6e-e053-2991aa0aa6c62025-09-10Exact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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