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 34 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
T-Relief	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	2bd442ca-0bbe-0bc3-e054-00144ff8d46c	2023-03-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
Traumed	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	8cd4745f-2f4b-4cdf-868b-c5a089a16599	2023-03-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
Traumex	ARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOT	MediNatura Inc	335c8bec-f0c3-4b95-a6a6-5fda262be0e6	2023-03-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Traumeel	ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOT	Biologische Heilmittel Heel	9ff5c743-0e8f-4416-9964-c92b3abb54dd	2023-03-06	Warnings	Exact identifier unii: G0R4UBI2ZZ
Insulin Diluting Medium for NovoLog	WATER INJECTION	Novo Nordisk	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	2023-02-28	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS	Deseret Biologicals, Inc.	d29af0e7-0d04-47e3-9a50-d99c7e14b44d	2023-02-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS	Deseret Biologicals, Inc.	f267fff4-f331-49b8-bd48-7d383da52246	2023-01-11	Warnings	Exact identifier unii: G0R4UBI2ZZ
Rehydrate	AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN	ParaDocs All Natural, Inc.	648fab10-c46b-420f-a42c-6642009d83fb	2023-01-10	Warnings	Exact identifier unii: 059QF0KO0R
COLIC CP	AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.	Natural Creations, Inc.	7c2a2f6e-a332-4c68-a7a8-fdc390f1827e	2022-12-19	Warnings	Exact identifier unii: G0R4UBI2ZZ
Dr Talbots Infant Pain Fever Relief	CALENDULA OFFICINALIS 12X,CHAMOMILLA 12X,ECHINACEA ANGUSTIFOLIA 12X,EUPATORIUM PERFOLIATUM 12X,HEPAR SULPHURIS CALCAREUM 12X,SULPHUR 12X,FERRUM PHOSPHORICUM 12X,KALI MURIATICUM 6X	Talbot's Pharmaceuticals Family Products,LLC.	e881a3ce-8cf9-0ce6-e053-2995a90ae824	2022-12-16	Warnings	Exact identifier unii: G0R4UBI2ZZ
Childrens Cold and Cough Nighttime	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL	Walgreen Company	80c41b65-0411-4395-e053-2a91aa0a9df9	2022-12-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Rest	SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIAN	Hyland's Inc.	5e9924be-4dad-324a-e053-2a91aa0a8ec1	2022-12-13	Warnings	Exact identifier unii: G0R4UBI2ZZ
CALMS FORTE	AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER	Hyland's Inc.	f48a35d4-aa0c-48b1-a2ad-a614ea2894e8	2022-12-07	Warnings	Exact identifier unii: G0R4UBI2ZZ
Yonis Bliss	CHAMOMILLA, NATRUM MURIATICUM	Brookhaus Essentials LLC	ea4091d6-d295-41a0-aae5-68f3c260e110	2022-11-30	Warnings	Exact identifier unii: G0R4UBI2ZZ
Refresh Digital PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	97e83e68-6374-4df4-93f6-d707fc32748d	2022-11-28	Warnings	Exact identifier unii: PDC6A3C0OX
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier unii: PDC6A3C0OX
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: G0R4UBI2ZZ
Unda 24	CRATAEGUS FRUIT, PASSIFLORA INCARNATA, BOLDO LEAF, VALERIANA OFFICINALIS ROOT, CHAMOMILLA, ALUMINIUM METALLICUM	Seroyal USA	0fd99c06-1ea8-7171-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: G0R4UBI2ZZ
UNDA 35	AURUM METALLICUM, CORALLIUM RUBRUM EXOSKELETON, CRATAEGUS, GRINDELIA, HAMAMELIS VIRGINIANA, MENTHA PIPERITA, MYRTUS COMMUNIS	Seroyal USA	1f64baba-eb29-30c6-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: 79M2M2UDA9
Unda 46	ABSINTHIUM, JATEORHIZA PALMATA ROOT, CONDURANGO BARK, MENTHA PIPERITA, ALOE SOCOTRINA, ARGENTUM METALLICUM	Seroyal USA	0ea95597-120a-2b06-e054-00144ff8d46c	2022-11-09	Warnings	Exact identifier unii: 79M2M2UDA9

Reported adverse events (FAERS/openFDA)#

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