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 88 of 172 · 3,421 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-52AETHUSA CYNAPIUM, APOMORPHINE HYDROCHLORIDE, ANAMIRTA COCCULUS SEED, COLCHICUM AUTUMNALE BULB, IPECAC, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM ROOT, AND KEROSENEDNA Labs, Inc.d454b66a-c55c-4082-b7c4-a90f43d2d4422025-01-13WarningsExact identifier
unii: 269XH13919
D-54DIBASIC POTASSIUM PHOSPHATE, SEPIA OFFICINALIS JUICE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, ARSENIC TRIOXIDE, AND SEMECARPUS ANACARDIUM JUICEDNA Labs, Inc.68a206a8-6f66-4957-843c-4c4c0636e78f2025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-64CHAMAELIRIUM LUTEUM ROOT, POTASSIUM ARSENITE ANHYDROUS, PHOSPHORUS, LEAD, AND SOLIDAGO VIRGAUREA FLOWERING TOPDNA Labs, Inc.ff5d5ebd-4cfa-45cd-8e27-7012dc44ff882025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-49ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIC SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PRATENSIS, SEPIA OFFICINALIS JUICE, AND SULFURDNA Labs, Inc.26800b04-81c7-4094-afe8-4db6ca878f6d2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
unii: 1MBW07J51Q
D-35ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, AND BRYONIA ALBA ROOTDNA Labs, Inc.275cc8ec-30ed-4dd9-815c-d082ee5b3a992025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-103ALUMINUM OXIDE, SILVER, GOLD, BERYLLIUM, CADMIUM, COPPER, CALCIUM SULFIDE, MERCURIC SULFATE, MOLYBDENUM, NICKEL, PLANTAGO MAJOR, PLATINUM, LEAD, ANEMONE PRATENSIS, SELENIUM, AND TINDNA Labs, Inc.f4efd03d-3f80-4694-9a02-b71b7e3e3f0d2025-01-13WarningsExact identifier
unii: 1MBW07J51Q
D-45SILVER NITRATE, ARNICA MONTANA, ARUM MACULATUM ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND PHOSPHORUSDNA Labs, Inc.ef1b1a20-8215-4b63-8f4c-4158c3dec0622025-01-13WarningsExact identifier
unii: 27YLU75U4W
D-47FERULA ASSA-FOETIDA RESIN, ARABICA COFFEE BEAN, NITROGLYCERIN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, AND ANEMONE PRATENSISDNA Labs, Inc.43bc349f-016d-41c8-88db-2e42abdf63ba2025-01-13WarningsExact identifier
unii: 3SW678MX72
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-96CATNIP, MATRICARIA CHAMOMILLA, GINGER, AND MENTHA PIPERITADNA Labs, Inc.88a53b92-fd44-40b6-ae8f-5b318757f6d02025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-61TOBACCO LEAF, SALIX NIGRA BARK, CAMPHOR (NATURAL), TURPENTINE OIL, BERBERIS VULGARIS ROOT BARK, SOLANUM DULCAMARA WHOLE, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM LEAF, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.5582d3d0-cf33-45d8-b3fb-5bf85e15bdfa2025-01-13WarningsExact identifier
unii: 269XH13919
D-75CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA CHAMOMILLA, BLACK COHOSH, CUPRIC ACETATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND VIBURNUM OPULUS BARKDNA Labs, Inc.28558d59-8e55-4a72-8d42-de3f54d4ebbb2025-01-13WarningsExact identifier
unii: G0R4UBI2ZZ
D-102GARLIC, ALOE, MYCOBACTERIUM TUBERCULOSIS, EUCALYPTUS GLOBULUS LEAF, CANIS LUPUS FAMILIARIS MILK, COW MILK, RANCID BEEF, DELPHINIUM STAPHISAGRIA SEED, STAPHYLOCOCCUS EPIDERMIDIS, STAPHYLOCOCCUS HAEMOLYTICUS, STAPHYLOCOCCUS SIMULANS, STREPTOCOCCUS PYOGENES, AND SULFURDNA Labs, Inc.d64022f6-e3e1-459b-b896-843c2a92d9da2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-84MILK THISTLE, BOS TAURUS BILE, SULFUR, THALLOUS ACETATE, AND ACTIVATED CHARCOALDNA Labs, Inc.d33c34b1-6121-4875-8974-f074d88f212f2025-01-13WarningsExact identifier
unii: 70FD1KFU70
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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