FDA.reportPublic FDA data

NDC 54973-4110-01 - 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
54973-4110
Requested NDC
54973-4110-01
Package NDCs from labels
54973-4110-1, 54973-4110-01
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
Hyland's Naturals Kids Cold & Cough Daytime Grape FlavorHyland's Consumer Health Inc.2022-08-16HUMAN 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
54973-4110-1Kids Cold and Cough Daytime Grape Flavor1 in 1 CARTONLIQUID11
54973-4110-1Kids Cold and Cough Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4110KIDS 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 NDC20230927_e6ffd6d1-fcfb-547d-e053-2995a90af9b6.zip
54973-4110KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR) LIQUID [HYLAND'S CONSUMER HEALTH INC.]1Current NDC, Legacy NDC, 2 package rows20221201_e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d.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 3 of 162 · 3,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Comfort Down There HemorrhoidsAESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9CSEVENE USA55001764-8bc9-cbac-e063-6394a90a455c2026-08-18WarningsExact identifier
unii: I76KB35JEV
Cold Comfort Cold and CoughALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5CSEVENE USA54e9282a-604d-4acd-e063-6394a90a59ff2026-08-18WarningsExact identifier
unii: I76KB35JEV
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ZW3Z11D0JV
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BM BM125 DROPSARSENIC ALBUM, DOLICHOS, HEPAR SULPH, MEZEREUM, RANUNCULUS BULB, RHUS TOXBM Private Limited5903117f-5278-a1bc-e063-6294a90a8f642026-08-14WarningsExact identifier
unii: 1MBW07J51Q
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
BM BM220 DROPSBAPTISIA, CHAMOMILLA, CHINA OFF, COLOCYNTHIS, DULCAMARA, MERC DUL, PODOPHYLLUMBM Private Limited590adab5-9c66-e7e2-e063-6394a90a6b4c2026-08-14WarningsExact identifier
unii: FGL3685T2X
Natural Lift Lack of energy - FatigueAVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9CSEVENE USA551194c4-dfd8-c42d-e063-6294a90aecee2026-08-13WarningsExact identifier
unii: 451W47IQ8X
BM BM53 DROPSAPIS MELLIFICA, APIUM VIRUS, ARSENIC ALB., BRYONIA ALBA, SULPHURBM Private Limited58eeb0eb-d09a-b979-e063-6394a90ad84d2026-08-13WarningsExact identifier
unii: 70FD1KFU70
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: 1MBW07J51Q
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
unii: 70FD1KFU70
Lymphastat FECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, ABIES NIGRA, BORAX, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SEPIA, THUJA OCCIDENTALIS, SKATOLUM, CANDIDA ALBICANSEnergique, Inc97467eb0-a08b-4223-b54a-af1d910577e82026-08-11WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
HepatoneCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.51064a35-bf55-4905-a305-7b80a29417e92026-08-11WarningsExact identifier
unii: 27YLU75U4W
Arterioforce IIBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, HYDRASTIS CANADENSIS, KALI IODATUM, ARNICA MONTANA, CACTUS GRANDIFLORUS, PROPOLIS, BARYTA CARBONICA, CONIUM MACULATUM, SECALE CORNUTUMBioActive Nutritional, Inc.ef98fbda-6815-4d0d-b07e-62ce420c4dee2026-08-11WarningsExact identifier
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

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