FDA.reportPublic FDA data

NDC 54973-4113-01 - Kids Cough and Mucus Daytime Grape Flavor

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
54973-4113
Requested NDC
54973-4113-01
Package NDCs from labels
54973-4113-1, 54973-4113-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's INC
Effective date
2024-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CITRIC ACID MONOHYDRATE - Hyland's Consumer Health Inc. | Hyland's INCHyland's Consumer Health Inc. | Hyland's INC2024-04-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor1 in 1 CARTONLIQUID13
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4113KIDS COUGH AND MUCUS DAYTIME GRAPE FLAVOR (BRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S CONSUMER HEALTH INC.]3Current NDC, Legacy NDC, 2 package rows20240425_e72c8fdb-2679-86b3-e053-2a95a90a6cdf.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 19 of 119 · 2,366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeoRelief for Menstrual Pain and CrampsHOMEOPATHIC PAIN RELIEF GELBioLyte Laboratories, LLC71c2a2f7-4823-51cb-e053-2995a90a5fb82026-01-27WarningsExact identifier
unii: T7J046YI2B
NEORELIEF FOR PAINTOPICAL GEL FOR PAINBioLyte Laboratories, LLC46df076d-4e3a-6faa-e054-00144ff8d46c2026-01-27WarningsExact identifier
unii: T7J046YI2B
Joint Tonic R IGINKGO BILOBA, DIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, VISCUM ALBUM, PINUS SYLVESTRIS, APIS MELLIFICA, DULCAMARA, KALMIA LATIFOLIA, LYCOPODIUM CLAVATUM, SULPHURBioActive Nutritional, Inc.183e5794-76a4-450f-9686-7828e46855a32026-01-21WarningsExact identifier
unii: 2788Z9758H
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: 91GQH8I5F7
NeurotoxAGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, GADOLINIUM METALLICUM, GERMANIUM SESQUIOXIDE, HOLMIUM METALLICUM,BioActive Nutritional, Inc.73fb4038-40b5-4b5b-8ded-f510d0411c952026-01-21WarningsExact identifier
unii: 27YLU75U4W
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Pulmo EchinaceaPULMO ECHINACEAUriel Pharmacy Inc.14c19a33-ffcc-4b35-a0cc-9f8d44cbaf662026-01-16WarningsExact identifier
unii: 91GQH8I5F7
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
unii: PDC6A3C0OX
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
unii: PDC6A3C0OX
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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