NDC 54973-3243-01 - 4 KIDS COLD N COUGH GRAPE FLAVOR

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
54973-3243
Requested NDC
54973-3243-01
Package NDCs from labels
54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4, 54973-3243-5, 54973-3243-01
Manufacturer
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 Kids Cold & Cough Daytime Natural Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
4 KIDS COLD N COUGH GRAPE FLAVOR - Hyland's Inc. | Applied Laboratories, IncHyland's Inc. | Applied Laboratories, Inc2025-02-20HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Value PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2019-11-21HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Combo PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2016-06-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR118 mL in 1 BOTTLE, PLASTICLIQUID11817
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR236 mL in 1 BOTTLE, PLASTICLIQUID23617
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-34 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR148 mL in 1 BOTTLE, PLASTICLIQUID14817
54973-3243-54 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-32434 KIDS COLD N COUGH GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR) LIQUID [HYLAND'S INC.]15Current NDC, Legacy NDC, 8 package rows20240711_798e2a4d-da2d-4bbd-a9b8-574490ef7357.zip
54973-32434 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip
54973-32434 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]3Current NDC, Legacy NDC20250223_1a297e56-4cb8-75ca-e063-6294a90a592b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3243-1ML - Milliliter54973-32437d28e6b8-49a4-4b0d-a073-9caf269e10c612024-06-10

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 100 of 172 · 3,421 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emvita 5BUFO RANA, CUPRUM METALLICUM, GLANDULA SUPRARENALIS, PHOSPHORUS, PULSATILLA, ZINCUM METALLICUMRUBIMED AG2a141ded-a864-422f-8eb4-69d65fb59c152024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Chavita 5PHOSPHORUS, THUJA OCCIDENTALIS, THYROIDINUM, VIOLA TRICRUBIMED AG583f0e23-e2ab-4756-9d86-33421086e3c82024-10-29WarningsExact identifier
unii: 27YLU75U4W
Nat MurNATRUM MURIATICUMEnergique, Inc.39c4cb25-e70f-4d5a-b7b6-1b62527aa4f32024-10-29WarningsExact identifier
unii: 451W47IQ8X
Menopause HPBELLADONNA, LACHESIS MUTUS, MANGANUM ACETICUM, NUX VOMICA, PULSATILLA (PRATENSIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISEnergique, Inc.6412a5f1-5587-4d4e-8d3f-6929794154362024-10-29WarningsExact identifier
unii: 269XH13919
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC68cc9c41-ed24-4f76-8efb-2936ae3ddd8d2024-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, FAGOPYRUM ESCULENTUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.d008a091-b7c6-41f1-a1cf-f8224ebe55e52024-10-29WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
PulmoparLOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUREnergique, Inc.1cfb69c5-dc01-4acc-8053-5ca4e64165dc2024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
MetalstatALLIUM SATIVUM, AVENA SATIVA, BERBERIS VULGARIS, LAPPA MAJOR, SOLIDAGO VIRGAUREA, PHYTOLACCA DECANDRA, LYCOPODIUM CLAVATUM, NUX VOMICA, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUM, MOLYBDENUM,Energique, Inc.09be5ddd-06c9-4003-9727-442363fb8d6f2024-10-29WarningsExact identifier
unii: 269XH13919
Multi-Cell SaltKALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEAEnergique, Inc.dad00225-b3ac-4e36-a856-19b0faf42c422024-10-29WarningsExact identifier
unii: 451W47IQ8X
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 2788Z9758H
unii: 451W47IQ8X
Numbness HPACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, COFFEA CRUDA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMEnergique, Inc.0c4ba547-b4b4-41d0-8a6b-1141ff5f94532024-10-29WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
unii: 492225Q21H
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.Energique, Inc.76c6b494-43d1-4508-bea4-4f9026b4a5fa2024-10-29WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
PostpituaparAPIS MELLIFICA, ARSENICUM ALBUM, LACHESIS MUTUS, NUX VOMICA, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, THUJA OCCIDENTALISEnergique, Inc.1212410f-ebe9-40b8-85f6-27bd45456e4a2024-10-29WarningsExact identifier
unii: 269XH13919
Nut AntigensALMOND (NUT), CASHEW (NUT), BLACK WALNUT (NUT), PECAN (NUT), COCONUT, OLEUM OLEA EUROPAEA, CHESTNUT (NUT), WATER CHESTNUT (NUT), PINENUT (NUT), MACADAMIA (NUT), PISTACHIO (NUT), PEANUT (NUT), ENGLISH WALNUT (NUT), BRAZIL NUT (NUT), HAZELNUT (NUT), ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SULPHUR, CARYA ALBAEnergique, Inc.e95845f0-26d1-4190-bb45-e5f276a2bba42024-10-29WarningsExact identifier
unii: 70FD1KFU70
unii: I76KB35JEV
Pre/Post SurgetoneHYPERICUM PERFORATUM, RHUS TOX, STAPHYSAGRIA, SYMPHYTUM OFFICINALE, ARNICA MONTANA, PHOSPHORUS, CALENDULA OFFICINALISEnergique, Inc.8cbe3be1-e50c-4ad9-ab15-c696059f03a22024-10-29WarningsExact identifier
unii: 27YLU75U4W
Jointstat BBCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOXEnergique, Inc.f0da5560-8025-4c2c-afaf-6f5fb92f90e82024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
IndustristatPLANTAGO MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CADMIUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMEnergique, Inc.1279a90c-6263-4ca6-87e1-4b31a36854bb2024-10-28WarningsExact identifier
unii: 269XH13919
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
LipostatCAPSICUM ANNUUM, FUCUS VESICULOSUS, BORAGE OFFICINALIS, LECITHIN, CALCAREA CARBONICA, FERRUM METALLICUM, KALI BICHROMICUM, KALI CARBONICA, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87309894-d054-4b2f-aeba-bccd25b45f542024-10-28WarningsExact identifier
unii: 70FD1KFU70
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 27YLU75U4W
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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