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 49 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowerSpot CleanseSULFURBluemercury443ae172-bacd-4122-8d78-d2214bcb02fd2025-12-09WarningsExact identifier
unii: 70FD1KFU70
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DANDI HPMILK THISTLE, DYSPHANIA AMBROSIOIDES, BOS TAURUS BILE, GOLDEN SEAL, POTASSIUM TARTRATE HEMIHYDRATE, TARAXACUM OFFICINALE, IODINE, ARSENIC TRIOXIDE, OSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CHLORIDE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUSNatural Creations, Inc.44c7d388-6c40-47e2-9760-4e5075fc0e7b2025-12-08WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Cartilago BetulaCARTILAGO BETULAUriel Pharmacy Inc.99037dd6-b2c8-45d0-bb5f-670aed53ee462025-12-08WarningsExact identifier
unii: 492225Q21H
Cough and BronchialACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America791a8da1-0de3-4798-bbc9-b3538ea28dd72025-12-08WarningsExact identifier
unii: 1MBW07J51Q
Cough and Bronchial Daytime SyrupACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe Mexico, S.A. de C.V.e8949f67-1b05-40a2-96a5-d4d1124915ff2025-12-08WarningsExact identifier
unii: 1MBW07J51Q
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
unii: 27YLU75U4W
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCd20768fe-4516-483a-a082-ff1df9ad1d992025-12-06Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
Cough and Bronchial Nighttime SyrupACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe Mexico S.A. DE C.V.00d38f6f-dbab-4bbd-84b5-9807ea9073f82025-12-04WarningsExact identifier
unii: 3SW678MX72
unii: 1MBW07J51Q
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 70FD1KFU70
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
Nightime Cough and BronchialACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe North Americab3899e48-2db8-4deb-b976-eb143b6223dd2025-12-04WarningsExact identifier
unii: 3SW678MX72
unii: 1MBW07J51Q
THE FLOWER REMEDY Happy HeartGENTIANELLA AMARELLA, ULEX EUROPAEUS, ILEX AQUIFOLIUM, LONICERA CAPRIFOLIUM, SINAPIS ARVENSIS, ORNITHOGALUM UMBELLATUM, CASTANEA SATIVA, SALIX VITELLINA, IGNATIA AMARA, NATRUM MURIATICUMThe Flower Remedy6decd8fe-7593-4421-926c-f924002400322025-12-03WarningsExact identifier
unii: 451W47IQ8X
ProstateTHYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGONewton Laboratories, Inc.9ca8f252-a14f-3990-e053-2995a90af8d72025-12-03WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
ProstateTHYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGONewton Laboratories, Inc.9986d25e-f4c2-51d3-e053-2a95a90a85482025-12-03WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
Adult AcnomelRESORCINOL, SULFURNUMARK BRANDS, INC90f80e35-095d-88f9-8ea3-0fd54f1e916c2025-12-03WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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