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 36 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChamomillaCHAMOMILLAOHM PHARMA INC.eddff8d8-ec79-4d09-addf-bedb6c1847aa2021-12-30WarningsExact identifier
unii: G0R4UBI2ZZ
Arnica Plus DROPSACONITUM NAPELLUS, ARNICA MONTANA, CHAMOMILLA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, BELLADONNA, COLOCYNTHIS, RHUS TOX, FERRUM PHOS, MAGNESIUM PHOS.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics54402c83-02bd-434e-a27e-b55b3fedcfc52021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Arnica WellBELLIS PERENNIS, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLLIUM MT, CHAMOMILLA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, APIS MELLIFICA, ARNICA MONTANA, BELLADONNA, SYMPHYTUM OFFICINALE, HYPERICUM PERFORATUM.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 05258499752647581-e65c-4f43-bb61-600174bc8e7e2021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Acne Relief GelCALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUROHM PHARMA INC.43f669ef-2ebd-46c8-adb6-84bea30a7c0b2021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Cough Relief SyrupALTHAEA, ANTIMON SULPH, ANTIMON TART, BRYONIA, CETRARIA, CHAMOMILLA, DROSERA, ECHINACEA ANG, IPECAC, KALI MUR, PLANTAGO, RUMEX CRISP, SENEGA, SPONGIA, THYMUS, TRIFOLIUM PRAT, URTICA DI, VERBASCUM.OHM PHARMA INC.5285cdbb-8502-4ff4-977a-cb3c5ae2cc9b2021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
OHM Fever ReliefACONITUM NAP, BAPTISIA, BELLADONNA, BRYONIA, CHAMOMILLA, EUPATORIUM PERF, GELSEMIUM, RHUS TOX.OHM PHARMA INC.d55c1ef6-f682-4d06-ace7-2ed773e35f852021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
OHM Skin Healing CreamCALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.OHM PHARMA INC.c12e6706-37f0-4900-856c-fc7e7ac3b7242021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
OHM Skin Healing GelCALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.OHM PHARMA INC.f97dffe6-cddc-4577-afcc-deadb7abd0c62021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
TrauleviumBELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.Medical Technology Products, Inc.6123d145-4edf-4ecd-8b30-196e522731272021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
TrauleviumARNICA MONTANA RADIX, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.Medical Technology Products, Inc.797f448f-a4c7-4c7a-980d-7c3b074e64992021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
TRAULEVIUM Pain Relief DropsARNICA RAD, ACONITUM NAP, CHAMOMILLA, BELLADONNA, SYMPHYTUM, BELLIS, CALENDULA, ECHINACEA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, MILLEFOLIUM, HEPAR SULPH CALC, MERC SOLUB.Medical Technology Products, Inc.1f9efd2d-16e2-4c34-b62a-3745d3c53c6b2021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Traulevium Pain Relief GelARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.Medical Technology Products, Inc.692daf7a-11e2-4f08-bdcf-1b9ac866d2132021-12-29WarningsExact identifier
unii: G0R4UBI2ZZ
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: G0R4UBI2ZZ
Dr. Talbots Pain Fever ReliefCALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, FERRUM PHOSPHORICUM, KALI MURIATICUMTalbot's Pharmaceuticals Family Products, LLC.91d50391-f6a7-febf-e053-2995a90a1b022021-10-05WarningsExact identifier
unii: G0R4UBI2ZZ
Dr. Talbots Pain Inflammation ReliefARNICA, BELLIS PERENNIS, CALENDULA OFFICINALIS, CHAMOMILLA, COFFEA CRUDA, HYPERICUM, MILLEFOLIUM, FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICATalbot's Pharmaceuticals Family Products, LLC.91d57aae-7c68-cc4a-e053-2995a90aad9d2021-10-05WarningsExact identifier
unii: G0R4UBI2ZZ
Dr. Talbots Gas Colic ReliefCARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUMTalbot's Pharmaceuticals Family Products, LLC91213655-92d2-64c2-e053-2995a90aaa5a2021-10-05WarningsExact identifier
unii: G0R4UBI2ZZ
Dr. Talbots Tummy Ache ReliefCALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUMTalbot's Pharmaceuticals Family Products, LLC91c1e0ae-9999-0ae2-e053-2995a90a2d712021-10-05WarningsExact identifier
unii: G0R4UBI2ZZ
CHAMOMILLACHAMOMILLARxhomeo Private Limited d.b.a. Rxhomeo, Inc7e21364d-0617-46a7-a03c-33c4273ecc072021-09-02WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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