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 36 of 119 · 2,366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIARRHEA CPAETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFURNatural Creations, Inc.06f51c41-1e76-4201-937a-cbaaf6a477af2025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
DigestionGENTIANA LUT, SAMBUCUS NIG, ARSENICUM ALB, BISMUTH SUB, CARBO VEG, KALI BIC, LYCOPODIUM, NUX VOM, PHOSPHORUS, PULSATILLANatural Creations, Inceabd9ea9-e61d-4c18-b95f-60c9ab1b3dd82025-12-10WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: I76KB35JEV
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
DANDI HPMILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDEN SEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUSNatural Creations, Inc.44c7d388-6c40-47e2-9760-4e5075fc0e7b2025-12-08WarningsExact identifier
unii: 27YLU75U4W
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Cough and BronchialACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America791a8da1-0de3-4798-bbc9-b3538ea28dd72025-12-08WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
Cough and Bronchial Daytime SyrupACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe Mexico, S.A. de C.V.e8949f67-1b05-40a2-96a5-d4d1124915ff2025-12-08WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCd20768fe-4516-483a-a082-ff1df9ad1d992025-12-06Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Cough and Bronchial Nighttime SyrupACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe Mexico S.A. DE C.V.00d38f6f-dbab-4bbd-84b5-9807ea9073f82025-12-04WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
Nightime Cough and BronchialACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe North Americab3899e48-2db8-4deb-b976-eb143b6223dd2025-12-04WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
ProstateTHYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGONewton Laboratories, Inc.9ca8f252-a14f-3990-e053-2995a90af8d72025-12-03WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
ProstateTHYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGONewton Laboratories, Inc.9986d25e-f4c2-51d3-e053-2a95a90a85482025-12-03WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
GallcillCHELIDONIUM MAJUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, DIOSCOREA VILLOSA, CALCAREA SULPHURICA, CUPRESSUS LAWSONIANA, HEPAR SULPHURICA CALCAREUM, CHOLESTERINUM, FEL TAURI, LYCOPODIUM CLAVATUM, MAGNESIA SULPHURICANucleic Products, LLCfaf3ac96-b744-448d-b41a-8370b3ef3c0c2025-12-03WarningsExact identifier
unii: 1MBW07J51Q
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 91GQH8I5F7
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 91GQH8I5F7

Reported adverse events (FAERS/openFDA)#

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