NDC 54973-3375-01 - 4 Kids Cold and Cough Nighttime

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
54973-3375
Requested NDC
54973-3375-01
Package NDCs from labels
54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-02-06
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 NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.]11Current NDC, Legacy NDC, 5 package rows20250209_71e93027-33c9-6147-e053-2a95a90aaa09.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 101 of 163 · 3,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
Healing SupportALLIUM SATIVUM, APIS MELLIFICA, ARGENTUM METALLICUM, CALCAREA FLUORICA, CALTHA PALUSTRIS, CLEMATIS ERECTA, ECHINACEA (ANGUSTIFOLIA), GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, NITRICUM ACIDUM, ONONIS SPINOSA, PHOSPHORUS, PYROGENIUM, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENSDeseret Biologicals, Inc.7bac4747-df9c-4de7-8898-80218632c3412024-09-26WarningsExact identifier
unii: 27YLU75U4W
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
unii: 451W47IQ8X
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
unii: 451W47IQ8X
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 2788Z9758H
Sodium Sulfacetamide 9% - Sulfur 4.5% WashSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.29c84706-b96b-45e8-b84a-b130a2d1e9b52024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% and Sulfur 4.8% CleanserSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.8f6809f0-10f9-4d1b-a8f6-6a6745b04dba2024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
DefensePETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUMNutritional Specialties, Inc.ddd879cf-1a85-4b8d-bdb0-5cf495fea4e62024-09-24WarningsExact identifier
unii: 451W47IQ8X
Sodium Sulfacetamide 10% and Sulfur 5% CleanserSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.7746061b-94e6-4e33-8a40-cf1ef16a198b2024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% - Sulfur 4%SULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.173fd4d6-1efb-46e3-bf8e-565a265b6d6e2024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4%SULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.bfbe625c-5679-4363-913a-2ab03198f4f02024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.2e58df3f-b59d-4333-b9f6-86598e848e9f2024-09-24Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Regen HPCINNAMOMUM, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LAPPA MAJOR, TRIFOLIUM PRATENSE, VISCUM ALBUMEnergique, Inc.ea11c312-b26c-45c7-b2fb-14edbedd69322024-09-24WarningsExact identifier
unii: ZW3Z11D0JV
TobaccoCHAMOMILLA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ALLIUM SATIVUM, ARGENTUM NITRICUM, AVENA SATIVA, CALADIUM SEGUINUM, KALI BICHROMICUM, LOBELIA INFLATA, LYCOPODIUM CLAVATUM, SEROTONIN (HYDROCHLORIDE), TABACUM, ADRENALINUM, AMMONIACUM GUMMI, BALSAMUM PERUVIANUM, CACTUS CACTI, SELENIUM METALLICUMDeseret Biologicals, Inc.68d6780a-e247-48d9-9a54-4b7c6a3e68162024-09-23WarningsExact identifier
unii: G0R4UBI2ZZ
LymphaparECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEAEnergique, Inc.c746c111-7ebc-46c1-b11b-04271887df9c2024-09-23WarningsExact identifier
unii: 1MBW07J51Q
HP AxisARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONEDeseret Biologicals, Inc.402f5b05-c71e-4dba-bc2b-049aee42952a2024-09-23WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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