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 59 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
D-4QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.45577059-73f4-4302-b299-3e356aaf959a2025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-8SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIADNA Labs, Inc.bc817ccf-f11c-4875-9e14-5a249f92c5032025-01-13WarningsExact identifier
unii: DL6OZ476V3
unii: 1MBW07J51Q
D-6ACONITUM NAPELLUS, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, CAUSTICUM, CAMPHOR (NATURAL), EUCALYPTUS GLOBULUS LEAF, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, AND SCHOENOCAULON OFFICINALE SEEDDNA Labs, Inc.27f58993-c611-4dc7-ac8e-0132f0a4fcef2025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-24BRYONIA ALBA ROOT, RANUNCULUS BULBOSUS, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM SULFATE ANHYDROUS, AND POTASSIUM CARBONATEDNA Labs, Inc.4247e932-d5e6-4465-ae82-763dbf43d7eb2025-01-13WarningsExact identifier
unii: T7J046YI2B
D-28CLAVICEPS PURPUREA SCLEROTIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, SAFFRON, FERROSOFERRIC PHOSPHATE, SULFURIC ACID, AND HORSE CHESTNUTDNA Labs, Inc.2e75490a-b63d-419b-8e33-72e30faea4502025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-36AMANITA MUSCARIA FRUITING BODY, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHOSPHORUS, AND ZINC VALERATE DIHYDRATEDNA Labs, Inc.0c658eda-70eb-4322-ade4-2ec7d7690aeb2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-12POTASSIUM IODIDE, CALCIUM IODIDE, ARSENIC TRIIODIDE, BARIUM CHLORIDE DIHYDRATE, NITROGLYCERIN, CONIUM MACULATUM FLOWERING TOP, ARNICA MONTANA, PHOSPHORUS, AND GOLD TRICHLORIDEDNA Labs, Inc.cd69e429-32af-4d77-9ec1-c40cfc7fe4142025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-9CUPRIC ACETATE, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, DROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, HYOSCYAMUS NIGER, ONION, CORALLIUM RUBRUM EXOSKELETON, AND LOBARIA PULMONARIADNA Labs, Inc.15cb964d-086f-40a6-8056-5f149f04ab4c2025-01-13WarningsExact identifier
unii: 62I3C8233L
D-46FERROSOFERRIC PHOSPHATE, LITHIUM CARBONATE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM LEAF, AND FILIPENDULA ULMARIA ROOTDNA Labs, Inc.be8b4acb-83c6-4d25-ba90-ee6e6e0a588e2025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: T7J046YI2B
D-74TRIBASIC CALCIUM PHOSPHATE, CAUSTICUM, FERROSOFERRIC PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, ANEMONE PRATENSIS, AND SEPIA OFFICINALIS JUICEDNA Labs, Inc.5f3afcfe-7494-46be-affa-4a1a8ec3616f2025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-38APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFURDNA Labs, Inc.5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa2025-01-13WarningsExact identifier
unii: T7J046YI2B
D-41PHOSPHORIC ACID, CHASTE TREE, CINCHONA OFFICINALIS BARK, TURNERA DIFFUSA LEAFY TWIG, PHOSPHORUS, SEPIA OFFICINALIS JUICE, BOS TAURUS TESTICLE, AND CONIUM MACULATUM FLOWERING TOPDNA Labs, Inc.3600d04a-bab5-440a-a2aa-908bf920620a2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-80BAPTISIA TINCTORIA ROOT, LACHESIS MUTA VENOM, ECHINACEA ANGUSTIFOLIA, BRYONIA ALBA ROOT, ACONITUM NAPELLUS, SOLIDAGO VIRGAUREA FLOWERING TOP, AND AVENA SATIVA FLOWERING TOPDNA Labs, Inc.83e4ab65-514d-47ab-9d99-147168587ab22025-01-13WarningsExact identifier
unii: T7J046YI2B
D-90SILVER, ECHINACEA ANGUSTIFOLIA, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.5b174b23-c2e7-4d7b-ba2a-11158187c8002025-01-13WarningsExact identifier
unii: 91GQH8I5F7
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-60CALCIUM SULFIDE, JUGLANS REGIA FRUIT RIND, IMMATURE, JUGLANS REGIA LEAF, MYOSOTIS ARVENSIS, SMILAX ORNATA ROOT, FUMARIA OFFICINALIS FLOWERING TOP, ARANEUS DIADEMATUS, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, AND GALIUM APARINEDNA Labs, Inc.5ff0e58c-d745-4c92-aef6-4f40168a49352025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-72APIS MELLIFERA, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, MOMORDICA BALSAMINA IMMATURE FRUIT, AND PHOSPHORUSDNA Labs, Inc.2646ff5c-0c06-456d-903a-df8aeca153162025-01-13WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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