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 31 of 38 · 760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS AND HYPERICUM PERFORATUMMediNatura Inc01804104-32c2-4011-a2e4-0f4e74bd974d2023-09-28WarningsExact identifier
unii: G0R4UBI2ZZ
T-Relief Extra Strength GelACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Ince4bf2e39-5635-4797-8519-7e115e8b1a272023-09-27WarningsExact identifier
unii: G0R4UBI2ZZ
T-ReliefACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, MATRICARIA RECUTITA, ATROPA BELLADONNA,COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS,ARNICA MONTANA, AND RUTA GRAVEOLENS FLOWERING TOPMediNatura Inc1fcfd0a5-b4ff-4546-e054-00144ff8d46c2023-09-27WarningsExact identifier
unii: G0R4UBI2ZZ
T-Relief Extra Strength CreamARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA UNSPECIFIED, ACONITUM NAPELLUS, ACHILLEA MILLEFOLIUM, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, BELLIS PERENNIS, RUTA GRAVEOLENS FLOWERING TOP, BAPTISIA TINCTORIA ROOT, COMFREY ROOT AND HYPERICUM PERFORATUMMediNatura Inc12f6cf2f-a924-42b1-9ca0-c360c7a592442023-09-27WarningsExact identifier
unii: G0R4UBI2ZZ
T-ReliefACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Incedb2fe62-e990-4cef-8600-9d1b85bffa5a2023-09-27WarningsExact identifier
unii: G0R4UBI2ZZ
TraumeelACONITUM 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 ROOTMediNatura Incc9962e63-3c30-4c62-9caf-91f663c7eeaa2023-09-26WarningsExact identifier
unii: G0R4UBI2ZZ
AllergiesAPIS 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, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: 79M2M2UDA9
unii: G0R4UBI2ZZ
Pancreas SarcodeCHAMOMILLA, GLYCYRRHIZA GLABRA, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUS, ACETICUM ACIDUM, CONDURANGO, PHASEOLUS, SARSAPARILLA (SMILAX REGELII), PANCREAS SUIS, URICUM ACIDUMNutritional Specialties, Inc.56a6dbc1-3a6b-444f-8082-1999a64e529c2023-09-25WarningsExact identifier
unii: G0R4UBI2ZZ
T-Relief Extra StrengthARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING, HAMAMELIS VIRGINIANA ROOT BARK/STEM, BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS, ECHINACEA, UNSPECIFIED, ACONITUM NAPELLUS, MATRICARIA CHAMOMILLA, ACHILLEA MILLEFOLIUM, ATROPA BELLADONNA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc97959b87-690d-45c1-9319-c17cdfa850202023-09-18WarningsExact identifier
unii: G0R4UBI2ZZ
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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