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 6 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
Upper Gi and Enzyme RestorationACETICUM ACIDUM, AGARICUS MUSCARIUS, ALOE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINCHONA OFFICINALIS, GRAPHITES, IPECACUANHA, LAC DEFLORATUM, MENTHA PIPERITA, NUX VOMICA, SECALE CORNUTUM, TANACETUM VULGARE, TEUCRIUM MARUM AND ZINGIBER OFFICINALE.King Bio Inc.84e268e5-ba68-4ad6-84d4-d799c4ea91ee2026-03-04WarningsExact identifier
unii: 79M2M2UDA9
Restless LegsARSENICUM ALBUM, CAUSTICUM, CHAMOMILLA, LYCOPODIUM CLAVATUM, PALLADIUM METALLICUM, PLATINUM METALLICUM, ZINCUM METALLICUMNaturalCare1e245ee1-b76f-49ed-9403-9d91d0492ab92026-03-02WarningsExact identifier
unii: G0R4UBI2ZZ
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
First Aid mind and BodyACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS ERECTA, CLEMATIS VITALBA, FLOS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, RHUS TOX, SULPHUR, SYMPHYTUM, TRIFOLIUM PRATENSE, AND VERATRUM ALBUM.King Bio Inc.20d4a0a3-7e69-4956-aaff-21703e2bb0302026-03-02WarningsExact identifier
unii: G0R4UBI2ZZ
Peace and QuietCHAMOMILLA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, MAGNESIUM MURIATICA, PASSIFLORA INCARNATANaturalCare412b02bf-1382-418d-bd75-b7bf344dcd4e2026-03-02WarningsExact identifier
unii: G0R4UBI2ZZ
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Chrysosplenium ChamomillaCHRYSOSPLENIUM CHAMOMILLAUriel Pharmacy Inc.d2c9746c-784b-4d76-874b-4f8ea6814f992026-02-27WarningsExact identifier
unii: G0R4UBI2ZZ
911 Stress and AnxiousnessACONITUM NAPELLUS, ALFALFA, APIS MELLIFICA, AVENA SATIVA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS VITALBA, FLOS, HISTAMINUM HYDROCHLORICUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, LILIUM TIGRINUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, PULSATILLA, AND VALERIANA OFFICINALIS.King Bio Inc.135d20b1-c87a-489b-b105-352b6048546a2026-02-27WarningsExact identifier
unii: G0R4UBI2ZZ
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Kids Cough and Mucus Nighttime Grape FlavorRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Consumer Health Inc.d83e7877-f599-b364-e053-2995a90ab35f2026-02-19WarningsExact identifier
unii: G0R4UBI2ZZ
CeleragesicACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), ECHINACEA PURPUREA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MILLEFOLIUM, NADIDUM, PANTOTHENIC ACID, RHUS TOX, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALEDeseret Biologicals, Inc.18e573b8-dd8d-432a-90c3-84b8929a40392026-02-18WarningsExact identifier
unii: G0R4UBI2ZZ
Dermveda ULTRA BITE ITCH RELIEFMENTHA PIPERITA, CURCUMA LONGACelcius Corp.232c344e-184d-4c95-bc2c-97c4c9cab0912026-02-16WarningsExact identifier
unii: 79M2M2UDA9
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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