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 60 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-57ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPOREDNA Labs, Inc.81cc16e7-921b-4b57-abeb-c44b9d72e4f32025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-48PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.1d55827f-0ea2-4eda-ae43-7c0723e5708e2025-01-13WarningsExact identifier
unii: 27YLU75U4W
unii: 91GQH8I5F7
unii: T7J046YI2B
D-37ALUMINUM OXIDE, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, AND SULFURDNA Labs, Inc.3b408532-b84b-4398-ab8d-64d5a9c8d0922025-01-13WarningsExact identifier
unii: T7J046YI2B
D-52AETHUSA CYNAPIUM, APOMORPHINE HYDROCHLORIDE, ANAMIRTA COCCULUS SEED, COLCHICUM AUTUMNALE BULB, IPECAC, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT, AND KEROSENEDNA Labs, Inc.d454b66a-c55c-4082-b7c4-a90f43d2d4422025-01-13WarningsExact identifier
unii: 62I3C8233L
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-62ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, FERROSOFERRIC PHOSPHATE, MERCURIUS SOLUBILIS, AND ANEMONE PRATENSISDNA Labs, Inc.1e70833f-5fcb-4e04-af34-ebe35d70321e2025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-64CHAMAELIRIUM LUTEUM ROOT, POTASSIUM ARSENITE ANHYDROUS, PHOSPHORUS, LEAD, AND SOLIDAGO VIRGAUREA FLOWERING TOPDNA Labs, Inc.ff5d5ebd-4cfa-45cd-8e27-7012dc44ff882025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-35ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, AND BRYONIA ALBA ROOTDNA Labs, Inc.275cc8ec-30ed-4dd9-815c-d082ee5b3a992025-01-13WarningsExact identifier
unii: T7J046YI2B
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-45SILVER NITRATE, ARNICA MONTANA, ARUM MACULATUM ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PHOSPHORUSDNA Labs, Inc.ef1b1a20-8215-4b63-8f4c-4158c3dec0622025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-124FERROSOFERRIC PHOSPHATEDNA Labs, Inc.04d46621-9654-4be6-84c2-c323f1e926b62025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: T7J046YI2B
D134BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATEDNA Labs, Inc.a1d4d74a-75ca-45f8-8787-7ac6aa7269322025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-110ARNICA MONTANA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, RUTA GRAVEOLENS FLOWERING TOP, FERROSOFERRIC PHOSPHATE, LACHESIS MUTA VENOM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, AND CALENDULA OFFICINALIS FLOWERING TOPDNA Labs, Inc.780ec514-9e36-4a4c-b947-960888fa7c752025-01-13WarningsExact identifier
unii: 27YLU75U4W
unii: 91GQH8I5F7
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-154ANAMIRTA COCCULUS, ARABICA COFFEE BEAN, ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITE, NUX VOMICA, PHOSPHORUS, POTASSIUM CARBONATE, SULFURDNA Labsf53e05de-043c-4eb4-e053-2995a90ad9cf2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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