FDA.reportPublic FDA data

NDC 54973-4112-01 - Kids Cold and Cough Combo Pack

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
54973-4112
Requested NDC
54973-4112-01
Package NDCs from labels
54973-4112-1, 54973-4112-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Kids Cold & Cough Combo Pack Grape FlavorHyland's Consumer Health Inc. | Hyland's Inc.2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4110-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4110-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4112-1Kids Cold and Cough Combo Pack1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4112KIDS COLD AND COUGH COMBO PACK (ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR) KIT [HYLAND'S CONSUMER HEALTH INC.]2Current NDC, Legacy NDC, 5 package rows20230927_e6ffd6d1-fcfb-547d-e053-2995a90af9b6.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 5 of 162 · 3,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
Metal-ChordALLIUM CEPA, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ALUMINA, ARSENICUM METALLICUM, BERBERIS VULGARIS, CADMIUM METALLICUM, CARDUUS MARIANUS, CETRARIA ISLANDICA, CUPRUM METALLICUM, CYSTEINUM, GLYCYRRHIZA GLABRA, HEPAR SUIS, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NUX VOMICA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PYRIDOXINUM HYDROCHLORICUM, SELENIUM METALLICUM, STILLINGIA SYLVATICA, THYROIDINUM, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALEEnergetix Corporationea4d26a8-acf2-46ed-9a69-df7764cc4cfd2026-08-11WarningsExact identifier
unii: 2788Z9758H
unii: 492225Q21H
Restful Legs PMANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPOREHyland's Inc.67667af8-b27b-1511-e053-2991aa0a39882026-08-11WarningsExact identifier
unii: 3SW678MX72
unii: 70FD1KFU70
Restful LegsARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINCHyland's Inc.36e5843c-916a-425c-becc-15674cda7a652026-08-11WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
dermveda ULTRA HEMORRHOID AND FISSURESULFUR, CURCUMA LONGACelcius Corp.044e0503-215b-4d57-96d9-62a54a8de4d12026-08-10WarningsExact identifier
unii: 70FD1KFU70
dermveda ATHLETES FOOTSULPHUR, CURCUMA LONGACelcius Corp.1741c97e-b178-4a37-a201-7b9610e06c8a2026-08-10WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Similasan Earache ReliefCHAMOMILE, MERCURIUS SOLUBILIS, SULFURSimilasan Corporation3b48e1d5-5e74-415b-a460-e4d96899dbb62026-08-05WarningsExact identifier
unii: FGL3685T2X
unii: 70FD1KFU70
Gluten Sensitivity FormulaLYCOPODIUM CLAVATUM, PULSATILLAThe Wise Alternative42b2d54a-5e02-44ed-8172-a45c5addf7c22026-08-04WarningsExact identifier
unii: I76KB35JEV
Easment Itch Defense Sulfur CreamSULFUR 1X HPUSEasment LLC5835f842-6428-0782-e063-6294a90ad1822026-08-04WarningsExact identifier
unii: 70FD1KFU70
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Jointox BBBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, BORRELIA BURGDORFERI NOSODE, BABESIA MICROTI, EHRLICHIA NOSODE (CANINE), HEPATITIS B NOSODE, MENINGOCOCCUS NOSODE, ARSENICUM ALBUM, BRYONIA (ALBA), CHELIDONIUM MAJUS, COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.acb949d3-1def-4a17-a159-a79614b8f77d2026-07-31WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
NeurostatCIMICIFUGA RACEMOSA, AGARICUS MUSCARIUS, COCCUS CACTI, CONIUM MACULATUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOX, TARENTULA CUBENSIS, LATRODECTUS MACTANS, PYROGENIUMEnergique, Inc.028d842f-3abd-421e-b6b8-07313ef690b82026-07-31WarningsExact identifier
unii: 27YLU75U4W
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
unii: 70FD1KFU70
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
unii: 70FD1KFU70
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
unii: 70FD1KFU70
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
unii: 1MBW07J51Q
GallbladderparCARDUUS MARIANUS, FEL TAURI, TARAXACUM OFFICINALE, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, SANGUINARIA CANADENSIS, GALLBLADDER (SUIS)Energique, Inc.1d68d6b0-a018-4450-af3c-103b976b46172026-07-31WarningsExact identifier
unii: 27YLU75U4W
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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