NDC 64616-119-01 - Gripe Water

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: 64616-119
Requested NDC: 64616-119-01
Package NDCs from labels: 64616-119-01, 64616-119-02
Manufacturer: Vitality Works | 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
Maxi-Health Gripe water	Vitality Works \| 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
64616-119-01	Gripe Water	59.1 mL in 1 BOTTLE, DROPPER	LIQUID	59.1		7
64616-119-02	Gripe Water	1 in 1 CARTON	LIQUID	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-119	GRIPE WATER LIQUID [VITALITY WORKS]	6	Current NDC, Legacy NDC, 2 package rows	20241212_45ade734-f446-4370-e054-00144ff88e88.zip

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 33 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
B HP	APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA	Energique, Inc.	8b1414d5-57d8-46d5-b4be-3011429bdd0d	2023-08-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
BHI Calming	MATRICARIA RECUTITA, ARABICA COFFEE BEAN, HOPS, STRYCHNOS IGNATII SEED, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SULFUR, VALERIAN, AND VERATRUM ALBUM ROOT	MediNatura Inc	681b7b04-9dd9-493a-88dc-b3178069a903	2023-08-02	Warnings	Exact identifier unii: G0R4UBI2ZZ
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f3bcf-0e45-d390-e063-6394a90a588e	2023-07-28	Warnings	Exact identifier unii: 79M2M2UDA9 unii: G0R4UBI2ZZ
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: 79M2M2UDA9 unii: G0R4UBI2ZZ
Melatonin Pro	CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)	Energique, Inc.	1f374642-83f7-4e64-b330-0f6ef21000a9	2023-07-19	Warnings	Exact identifier unii: G0R4UBI2ZZ
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: G0R4UBI2ZZ
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff5f22e1-74ee-1eee-e053-6394a90a2678	2023-06-30	Warnings	Exact identifier unii: G0R4UBI2ZZ
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff604442-4697-e2bb-e053-6394a90a0340	2023-06-30	Warnings	Exact identifier unii: G0R4UBI2ZZ
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fecece1f-22bc-21dc-e053-6294a90ad0c3	2023-06-23	Warnings	Exact identifier unii: G0R4UBI2ZZ
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fed03a1c-0ea8-1f8e-e053-6394a90a04c0	2023-06-23	Warnings	Exact identifier unii: G0R4UBI2ZZ
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	febf610e-e08a-4797-e053-6294a90a3eb5	2023-06-22	Warnings	Exact identifier unii: G0R4UBI2ZZ
Calciforce	ARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICA	BioActive Nutritional, Inc.	1609ce3e-82c2-4597-86e6-847c944ddbe6	2023-06-07	Warnings	Exact identifier unii: G0R4UBI2ZZ
BHI Back	AMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAF	MediNatura Inc	aa622a5b-16de-4098-9c3f-d7569f7d2c2f	2023-05-23	Warnings	Exact identifier unii: G0R4UBI2ZZ
Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	69485218-9343-952d-e053-2a91aa0ad4e8	2023-05-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	Hikma Pharmaceuticals USA Inc.	b20a28b0-7dfa-42eb-9177-ec256d5a5ef7	2023-05-08	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Baby Nighttime Mucus Plus Cold Relief	CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA	Hyland's Inc.	736b2487-e81d-d172-e053-2a91aa0ab0cf	2023-04-17	Warnings	Exact identifier unii: G0R4UBI2ZZ
Chamomilla	CHAMOMILLA	Newton Laboratories, Inc.	f912a32e-9bc9-c195-e053-6294a90a3e20	2023-04-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
Sterile Water	WATER	Civica, Inc.	3f49eedf-5bf5-4a95-b704-c956d860ca04	2023-04-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Treprostinil	TREPROSTINIL	Sandoz Inc	473297ca-a872-4052-a053-87dc8f0d3c13	2023-04-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Virility Liquescence	AVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIA	Nutritional Specialties, Inc.	81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f	2023-03-29	Warnings	Exact identifier unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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