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 47 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarAche Relief PMAPIS MELLIFICA, ARNICA MONTANA, CALCAREA PHOSPHORICA, CHAMOMILLA,ECHINACEA, HEPAR SULPHURIS CALCAREUM, HOITZIA, PASSIFLORA, VALERIANA OFFICINALISTRP Company92ee4f15-7315-7a46-e053-2995a90a7d0a2025-12-15WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
Asthma TherapyARSENIC TRIOXIDE - HISTAMINE DIHYDROCHLORIDE - DERMATOPHAGOIDES PTERONYSSINUS - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - STRYCHNOS NUX-VOMICA SEED - ASPIDOSPERMA QUEBRACHO-BLANCO BARK - SUPLHUR -TRP Company07d2988b-5012-481c-9b48-a709c33d29792025-12-15WarningsExact identifier
unii: 70FD1KFU70
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: 3SW678MX72
unii: 451W47IQ8X
Bronchial Cough TherapyANTIMONY POTASSIUM TARTRATE - PROTORTONIA CACTI - DROSERA ROTUNDIFOLIA - ECHINACEA, UNSPECIFIED - CALCIUM SULFIDE - HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - SPONGIA OFFICINALIS SKELETON, ROASTED -TRP Companyf87ad18c-689b-4279-8098-a075ce62bff72025-12-15WarningsExact identifier
unii: 1MBW07J51Q
ComPare2 Black Elderberry Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMTRP COMPANYa6231fe1-1f0f-04c8-e053-2a95a90a6ee72025-12-15WarningsExact identifier
unii: 70FD1KFU70
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: 451W47IQ8X
unii: ZW3Z11D0JV
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 10%, SULFUR 5%Aspen Medical LLC46064e69-cc19-8cee-e063-6394a90a8d322025-12-15Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Natural Relief Cough and Congestion Cough and Congestion Symptom ReliefANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUMTRP Company2a430f41-bd33-32af-e063-6394a90ae8012025-12-15WarningsExact identifier
unii: 451W47IQ8X
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: 1MBW07J51Q
Ring ReliefARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company1c9c7944-31a9-4019-aad5-6b7f86084b532025-12-15WarningsExact identifier
unii: 1MBW07J51Q
Ring Relief PM Nighttime FormulaARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company92ef0dd1-84f9-086c-e053-2a95a90ac6472025-12-15WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
unii: 1MBW07J51Q
ViscumforcePASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AURUM METALLICUM, BARYTA CARBONICA, GLONOINUM, PHOSPHORUS, PLUMBUM METALLICUM, VISCUM ALBUMBioActive Nutritional, Inc.5848e409-f0b5-4323-ad00-8d058e85aaf42025-12-15WarningsExact identifier
unii: 27YLU75U4W
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
Respo-KCALC SULPH, FERRUM PHOS, HEPAR SULPH CALC, SAMBUCUS NIG, VERBASCUMSILVER STAR BRANDSb727168c-0cb3-6a6a-e053-2995a90a0af02025-12-12WarningsExact identifier
unii: 1MBW07J51Q
Sinu-RiteGLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUSSILVER STAR BRANDSb79e177c-6bd7-2f9a-e053-2a95a90abedb2025-12-12WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
unii: I76KB35JEV
AmazaPetALTHAEA, ARSENICUM ALB, INULA, KALI MUR, MAG PHOSSILVER STAR BRANDSb724bc91-d3e1-290e-e053-2a95a90a26252025-12-12WarningsExact identifier
unii: 27YLU75U4W
GERM HPAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.15dc5391-0e6e-45d9-8ac7-142333a907162025-12-12WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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