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 44 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a032a72-eceb-204d-e053-2a95a90a670d2025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a035784-4144-2788-e053-2a95a90ab6182025-01-09Exact identifier
unii: U0NQ8555JD
Aconitum napellusACONITUM NAPELLUSHahnemann Laboratories, Inc.9a146e6b-95ca-22e0-e053-2a95a90a6b142025-01-09Exact identifier
unii: U0NQ8555JD
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-6LEMON, ORANGE, AND GRAPEFRUITDNA Labs, Inc.b5cf44e0-09cd-48ef-9132-cf6e93bdd4292025-01-09WarningsExact identifier
unii: O82C39RR8C
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: G0R4UBI2ZZ
AM-8ATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, AND FORMICA RUFADNA Labs, Inc.c313d3e3-11a2-45f7-8b87-1bf5d10191372025-01-09WarningsExact identifier
unii: WQZ3G9PF0H
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: WQZ3G9PF0H
N-6APIS MELLIFERA, ATROPA BELLADONNA, LACHESIS MUTA WHOLE, ECHINACEA ANGUSTIFOLIA, SCROPHULARIA NODOSA, FERROUS IODIDE, AND BOS TAURUS LYMPHDNA Labs, Inc.319b1d8d-30e5-4745-899a-67443e22cec52025-01-09WarningsExact identifier
unii: WQZ3G9PF0H
N-15ECHINACEA ANGUSTIFOLIA, BAPTISIA TINCTORIA, POTASSIUM CHLORIDE, CALCIUM SULFIDE, FERROUS IODIDE, SULFUR IODIDE, AND BOS TAURUS THYMUSDNA Labs, Inc.fbcefa48-587a-43e1-b9c2-4afaef99f14a2025-01-09WarningsExact identifier
unii: 660YQ98I10
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 660YQ98I10
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 660YQ98I10
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
SnoreStop Extinguisher 120ATROPA BELLADONNA, EPHEDRA DISTACHYA FLOWERING TWIG, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, TEUCRIUM MARUMGreen Pharmaceuticals Inceb534a2f-53ed-3924-e053-2a95a90a03512025-01-08WarningsExact identifier
unii: WQZ3G9PF0H
SnoreStop Chewable Fast tabs 60ATROPA BELLADONNA,EPHEDRA DISTACHYA FLOWERING TWIG,HISTAMINE DIHYDROCHLORIDE,GOLDENSEAL,POTASSIUM DICHROMATE,STRYCHNOS NUX-VOMICA SEED,TEUCRIUM MARUMGreen Pharmaceuticals Inceb056b9a-e93b-37f7-e053-2995a90a1be12025-01-08WarningsExact identifier
unii: WQZ3G9PF0H
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst9508355e-e1ed-412b-e053-2a95a90aac8e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst951ffdc3-d54f-d5e1-e053-2a95a90a79e62025-01-08Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
COLDACONITUM NAPELLUS, ALLIUM CEPA, GELSEMIUM SEMP., ZINCUM GLUCONICUMHyland's Inc.120c1c96-dd70-4d54-e054-00144ff8d46c2025-01-08WarningsExact identifier
unii: U0NQ8555JD

Reported adverse events (FAERS/openFDA)#

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