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

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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 74 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Influenza	INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA	Newton Laboratories, Inc.	995ca26b-7afb-b8d4-e053-2a95a90a7d1a	2020-12-04	Warnings	Exact identifier unii: U0NQ8555JD
Injury-Rescue	ACONITUM NAP, ARNICA, BELLIS, CALENDULA, ECHINACEA, GELSEMIUM, HAMAMELIS, HYPERICUM, LEDUM, PHOSPHORUS, RHUS TOXICODENDRON, RUTA, STAPHYSAG., SYMPHYTUM, HYDRASTIS CANADENSIS.	Newton Laboratories, Inc.	995da3c4-d236-f212-e053-2a95a90a402f	2020-12-04	Warnings	Exact identifier unii: U0NQ8555JD
Lymphatic Drainer	ECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..	Newton Laboratories, Inc.	9a633bfa-188c-dd42-e053-2995a90ad3aa	2020-12-04	Warnings	Exact identifier unii: WQZ3G9PF0H
MacDee	ACONITUM NAPELLUS, AURUM METALLICUM, BARYTA CARBONICA, BELLADONNA, CROTALUS HORRIDUS, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, MERCURIUS VIVUS, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, PULSATILLA, RHUS TOXICODENDRON, STRAMONIUM, THERIDION, ELAPS CORALLINUS.	Newton Laboratories, Inc.	9a6409d4-89f3-1ab8-e053-2995a90a3f1f	2020-12-04	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Multi-System	ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, ARALIA QUINQUEFOLIA, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, ECHINACEA, IODIUM, KALI CARBONICUM, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, CANDIDA ALBICANS, THYROIDINUM, USTILAGO MAIDIS, ASPERGILLUS NIGER, CLADOSPORIUM	Newton Laboratories, Inc.	9a65b40b-873b-346a-e053-2995a90aa968	2020-12-04	Warnings	Exact identifier unii: U0NQ8555JD
Muscle-Tendon	ACONITUM NAP., ANTIMON. TART.,ARG. NIT., ARNICA, BRYONIA, CHAMOMILLA,CHELIDONIUM MAJUS, CIMICIFUGA, EUPATORIUM PERF.,HYPERICUM, NUX VOM., RHUS TOXICODENDRON, RUTA,SARCOLACTICUM AC., STRAMONIUM, STRYCHNINUM,CHAMOMILLA, PHYTOLACCA, RUTA, SYMPHYTUM.	Newton Laboratories, Inc.	9960c87f-f299-5d92-e053-2a95a90a7012	2020-12-04	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Nervousness - Anxiety	ACONITUM NAP., AMBRA, ANACARDIUM ORIENTALE, ARG. NIT., ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HYOSCYAMUS, HYPERICUM, IGNATIA, KALI PHOS., NUX VOM., SAMBUCUS NIG., STRYCHNINUM, THERIDION, VALERIANA, PASSIFLORA	Newton Laboratories, Inc.	99706ce2-d555-88ca-e053-2a95a90abb4b	2020-12-04	Warnings	Exact identifier unii: U0NQ8555JD unii: G0R4UBI2ZZ
Neuro-Care	CHAMOMILLA, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CINCHONA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, IGNATIA AMARA, KALMIA LATIFOLIA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MEZEREUM, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, STRAMONIUM, STRYCHNINUM, VERBASCUM THAPSUS.	Newton Laboratories, Inc.	9a9dd847-0535-1257-e053-2995a90a1939	2020-12-04	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Oral Care-Gingivitis	ACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEA	Newton Laboratories, Inc.	9971a7f4-c02c-02ba-e053-2a95a90a2b73	2020-12-04	Warnings	Exact identifier unii: W2469WNO6U unii: WQZ3G9PF0H unii: U0NQ8555JD unii: G0R4UBI2ZZ
Exhaustion	ACONITUM NAP., ADRENALINUM, ARALIA QUINQUEFOLIA, ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CINCHONA, IODIUM, KALI CARB., KALI IOD., LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABAL, THYROIDINUM, ECHINACEA, GINGKO, PHYTOLACCA.	Newton Laboratories, Inc.	98fc56b6-afed-2cfd-e053-2995a90a59ae	2020-12-03	Warnings	Exact identifier unii: U0NQ8555JD
Fear	ACONITUM NAP., ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOSPHORUS, SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANA	Newton Laboratories, Inc.	99485faf-aee1-6482-e053-2a95a90a498b	2020-12-03	Warnings	Exact identifier unii: U0NQ8555JD
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9a61f1ae-d3a4-68d7-e053-2a95a90a4333	2020-12-03	Warnings	Exact identifier unii: U0NQ8555JD
G-Inflamm	CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, COLOCYNTHIS, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IPECACUANHA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MAGNESIA PHOSPHORICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, ZINGIBER OFFICINALE.	Newton Laboratories, Inc.	9a153c45-0142-5abb-e053-2995a90a71f5	2020-12-03	Warnings	Exact identifier unii: G0R4UBI2ZZ
Glauco	ACONITUM NAPELLUS, AURUM METALLICUM, BELLADONNA, CAUSTICUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, NUX VOMICA, OSMIUM METALLICUM, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, RHUS TOXICODENDRON, SPIGELIA ANTHELMIA.	Newton Laboratories, Inc.	9a6394e7-14ed-ced1-e053-2995a90aeb88	2020-12-03	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Headache-Migraine	ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..	Newton Laboratories, Inc.	994a037b-7165-3a1e-e053-2a95a90ad7ff	2020-12-03	Warnings	Exact identifier unii: WQZ3G9PF0H
Appetite - Craving Control	CHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUM	Newton Laboratories, Inc.	98cf5293-2a47-5e15-e053-2995a90a9c3b	2020-12-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bact-In	ECHINACEA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, URTICA URENS, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, HYDRASTIS CANADENSIS, IODIUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, ANTHRACINUM, PYROGENIUM	Newton Laboratories, Inc.	9a9f61c8-1913-1e6d-e053-2a95a90a8356	2020-12-02	Warnings	Exact identifier unii: U0NQ8555JD
Blad-R	APIS MEL., BERBER. VULG., BRYONIA, CANTHARIS, CINCHONA, EQUISETUM HYEMALE, FERRUM PHOSPHORICUM, GELSEMIUM, JUNIPERUS COM., PAREIRA, PHOSPHORUS, PLANTAGO, PULSATILLA, SABAL, TEREBINTHINA, UVA-URSI, ECHINACEA, HYDRASTIS, LAPPA, SOLIDAGO	Newton Laboratories, Inc.	98cf954f-4b9e-c4ce-e053-2995a90a31d2	2020-12-02	Warnings	Exact identifier unii: W2469WNO6U
BronCare	ECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUM	Newton Laboratories, Inc.	98d0c6e4-5825-0361-e053-2a95a90aaddd	2020-12-02	Warnings	Exact identifier unii: C9TD27U172
Breast Care - Fibrocystic	BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM	Newton Laboratories, Inc.	98d01128-9887-12ce-e053-2a95a90a7329	2020-12-02	Warnings	Exact identifier unii: WQZ3G9PF0H unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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