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 18 of 39 · 771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CamiliaMATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOTLaboratoires Boiron24246729-2d45-4d83-bc25-39db03e266d42025-05-27WarningsExact identifier
unii: G0R4UBI2ZZ
Chamomilla 30XCHAMOMILLALaboratoire Schmidt-Nagel Inc.3362a2d9-9bbd-0490-e063-6294a90a30792025-05-20WarningsExact identifier
unii: G0R4UBI2ZZ
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
unii: PDC6A3C0OX
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c2025-05-16WarningsExact identifier
unii: PDC6A3C0OX
CHAMOMILLA 30C - 3-PackCHAMOMILLASEVENE USA31e1cdc7-b32f-d36c-e063-6294a90a27c02025-05-15WarningsExact identifier
unii: G0R4UBI2ZZ
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: PDC6A3C0OX
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
Childrens Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.32ece9d6-b346-6304-e063-6394a90a182d2025-04-16WarningsExact identifier
unii: G0R4UBI2ZZ
JBA GoutaminATRACTYLODES MACROCEPHALA ,CARICA PAPAYA,CURCUMA LONGA,FIBRAUREA TINCTORIA,PERILLA FRUTESCENS,PORIA COCOS,PIPER LOLOT,ZINGIBER OFFICINALE,SIEGESBECKIA ORIENTALISAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals9fd78237-dcf0-409b-8d98-4504c1eaceea2025-04-11WarningsExact identifier
unii: IN6Q3S3414
Chamomilla 7XMATRICARIA RECUTITATrue Botanica, LLC227daf6d-95e6-b320-e063-6394a90a10c02025-04-07WarningsExact identifier
unii: G0R4UBI2ZZ
SleepologyALFALFA, AVENA SATIVA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, GELSEMIUM SEMPERVIRENS, NUX MOSCHATA, PASSIFLORA INCARNATA, PIPER METHYSTICUM, VALERIANA OFFICINALISGenexa Inc.1e11f655-374c-59ac-e054-00144ff8d46c2025-04-02WarningsExact identifier
unii: G0R4UBI2ZZ
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
SleepCalmMATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUMBoironde0b458d-5f0a-78f4-e053-2995a90afe4b2025-03-07Exact identifier
unii: G0R4UBI2ZZ
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM236ARG. MET, ARNICA MONT, BRYONIA, CHAMOMILLA, RANUNCULUS BULB, RHUS TOX, RUTA GRAVBestmade Natural Products2f82b461-7059-eacf-e063-6294a90a2ca92025-03-04WarningsExact identifier
unii: G0R4UBI2ZZ
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
RexallEar Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURDolgencorp LLC59cfc7b4-faf0-4794-8911-d8745e12c6b82025-02-28WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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