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 73 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prostatone HPCLEMATIS ERECTA, CONIUM MACULATUM, LYCOPODIUM CLAVATUM, MERCURIUS CORROSIVUS, PULSATILLA (VULGARIS), SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISBioActive Nutritional, Inc2ccf602f-734a-4b2d-8d89-c410293f9eb92025-04-02WarningsExact identifier
unii: I76KB35JEV
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
ColdcalmONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE IONLaboratoires Boironaf4a4765-8255-44fb-821c-4345a2a45e2a2025-04-01WarningsExact identifier
unii: 492225Q21H
unii: I76KB35JEV
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEAilex Pharmaceuticals, LLC329655ae-c3c0-46b2-a925-e49777f2076b2025-03-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNAT MURBestmade Natural Productse9e9a4f6-5104-3c6f-e053-2995a90a11652025-03-21WarningsExact identifier
unii: 451W47IQ8X
Terramed Just Think Comfort GynoCare Probiotics for Vaginal UseOLEUROPEIN,HYDRASTIS CANADENSIS,BORAX,CALENDULA OFFICINALIS,LACTOBACILLUS FERMENTUMRida LLC86c9c1a9-452b-4bae-a13e-723e4fc87eef2025-03-21WarningsExact identifier
unii: ZW3Z11D0JV
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
Natural Eyes Pink Eye Relief Fast Dissolving TablesACONITUM NAPELLUS, APIS MELLIFICA, EUPHRASIA OFFICINALIS, NATRUM ARSENICICUM, SULPHURTRP Company30aca951-f896-42fd-e063-6294a90aba7e2025-03-19WarningsExact identifier
unii: 70FD1KFU70
Natural Eyes Pink Eye Relief Fast Dissolving TablesACONITUM NAPELLUS, APIS MELLIFICA, EUPHRASIA OFFICINALIS, NATRUM ARSENICICUM, SULPHURTRP Company30b558b5-db9e-06c0-e063-6294a90a03442025-03-19WarningsExact identifier
unii: 70FD1KFU70
Natural Eyes Complete Eye Relief Fast Dissolving TablesEUPHRASIA OFFICIANALIS, HOITZIA, MERCURIUS CORROSIVUS, RUTA GRAVEOLENS, SULPHURTRP Company30a1d9aa-3966-0b91-e063-6294a90ae72b2025-03-18WarningsExact identifier
unii: 70FD1KFU70
Baby Nighttime Oral Pain ReliefARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDEHyland' Inc.58ef86b7-5b38-1591-e053-2991aa0aa53e2025-03-17WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
GOODBYE ACNE THERAPEUTIC SULFUR MASKSULFURPETER THOMAS ROTH, LLC308ec305-dbf3-c6f9-e063-6294a90a14ec2025-03-17WarningsExact identifier
unii: 70FD1KFU70
Natural Eyes Allergy Eye Relief Fast Dissolving TablesALLIUM CEPA, APIS MELLIFICA, EUPHRASIA OFFICINALIS, HISTAMINE HYDROCHLORICUM, PULSATILLA, SABADILLA, SULPHURTRP Company3090869a-6a65-a6a5-e063-6394a90a9ed42025-03-17WarningsExact identifier
unii: 492225Q21H
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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