FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Maxi-Health Gripe waterVitality Works | Vitality Works, Inc.2025-12-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-119-01Gripe Water59.1 mL in 1 BOTTLE, DROPPERLIQUID59.17
64616-119-02Gripe Water1 in 1 CARTONLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-119GRIPE WATER LIQUID [VITALITY WORKS]6Current NDC, Legacy NDC, 2 package rows20241212_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 28 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STRE PLUSALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), CHAMOMILLA, KALI IODATUM, LAC CANINUM, AGARICUS MUSCARIUS, AILANTHUS GLANDULOSUS, APIS MELLIFICA, ARGENTUM NITRICUM, BAPTISIA TINCTORIA, BARYTA MURIATICA, CALCAREA CARBONICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, STRAMONIUM, ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS, PHYTOLACCA DECANDRADeseret Biologicals, Inc.8e03667e-ae6a-4930-b117-3b14d5d26cb22024-02-22WarningsExact identifier
unii: G0R4UBI2ZZ
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: G0R4UBI2ZZ
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Perfect SleepADENOSINUM 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 (BACH)Deseret Biologicals, Inc.6d934960-63c6-4536-bde3-38c26f8083dc2024-02-06WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.105975ec-82ea-dbfb-e063-6394a90a4fd12024-02-01WarningsExact identifier
unii: 79M2M2UDA9
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.0fb69003-c66c-97ad-e063-6394a90a4c9b2024-01-24WarningsExact identifier
unii: 79M2M2UDA9
Chamomilla 30cMATRICARIA RECUTITASEVENE USAe26bedb2-cd71-4550-b1b3-4f967363d45a2024-01-24WarningsExact identifier
unii: G0R4UBI2ZZ
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Sleep TightADENOSINUM 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 (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: G0R4UBI2ZZ
Natural Relief Patch for MOTION SICKNESSCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLC161ed609-6029-4e2e-a480-5b4c72defa7b2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
GoPatch Motion Sickness and Dizziness ReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc4730e15-20e0-37fa-e053-2a95a90a61812024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
AnxiousReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc3cebdf1-66b6-40ea-e053-2995a90ab4ca2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
Natural Relief Patch for MENSTRUAL CRAMPSBELLADONNA, CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, MAGNESIA PHOSPHORICA, NUX VOMICA, PULSATILLA.Centered Enterprises, LLC82162b47-b614-459f-8129-3fdece8853f62024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
GoPatch TummyReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc47320b5-75c2-36ef-e053-2995a90ad7932024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ
GoPatch HangoverReliefCALENDULA OFFICINALIS, CHAMOMILLA, SEPIA, TABACUM, COCCULUS INDICUS, NUX VOMICACentered Enterprises, LLCc45fb9bb-e266-6b4f-e053-2995a90a972f2024-01-15WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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