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 24 of 38 · 760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Care and Comfort CreamACONITUM NAPELLUS, ARNICA MONTANA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, COLOCYNTHIS, HYPERICUM PERFORATUM, PULSATILLA (PRATENSIS), RHUS TOX, SYMPHYTUM OFFICINALEEnergique, Inc.ac8ee81f-0af4-46d4-b63f-beeb7d120f802024-10-24WarningsExact identifier
unii: G0R4UBI2ZZ
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: G0R4UBI2ZZ
Trauma ReliefCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLADONNA, BELLIS PERENNIS, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, SYMPHYTUM OFFICINALE, RHUS TOX, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, CARBO VEGETABILISDeseret Biologicals, Inc.651f998a-c150-4f38-8582-b9bd971409102024-10-22WarningsExact identifier
unii: G0R4UBI2ZZ
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.aa8f0dd4-4a3e-49ab-85cf-e4a5f48cdbf52024-10-22WarningsExact identifier
unii: G0R4UBI2ZZ
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.d3d8a7f4-169c-4780-852d-c96a4772e7e32024-10-22WarningsExact identifier
unii: G0R4UBI2ZZ
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
unii: PDC6A3C0OX
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
unii: PDC6A3C0OX
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
TobaccoCHAMOMILLA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ALLIUM SATIVUM, ARGENTUM NITRICUM, AVENA SATIVA, CALADIUM SEGUINUM, KALI BICHROMICUM, LOBELIA INFLATA, LYCOPODIUM CLAVATUM, SEROTONIN (HYDROCHLORIDE), TABACUM, ADRENALINUM, AMMONIACUM GUMMI, BALSAMUM PERUVIANUM, CACTUS CACTI, SELENIUM METALLICUMDeseret Biologicals, Inc.68d6780a-e247-48d9-9a54-4b7c6a3e68162024-09-23WarningsExact identifier
unii: G0R4UBI2ZZ
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: G0R4UBI2ZZ
RageAPIS MELLIFICA, CANTHARIS, CHAMOMILLA, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ATROPINUM, CAUSTICUM, CICUTA VIROSA, CUPRUM METALLICUM, HYOSCYAMUS NIGER, LAC CANINUM, MOSCHUS, STRAMONIUM, TARENTULA HISPANA, VERATRUM ALBUM, HOMARUS, CAMPHORADeseret Biologicals, Inc.cb2e014a-dc0f-4bd2-b302-f1bc6d900e8e2024-09-11WarningsExact identifier
unii: G0R4UBI2ZZ
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,Deseret Biologicals, Inc.e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf2024-09-06WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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