FDA.reportPublic FDA data

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 134 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulphurSULFURBoiron86a57ea2-27de-0ed5-e053-2991aa0a50fc2023-01-23Exact identifier
unii: 70FD1KFU70
Natrum muriaticumSODIUM CHLORIDEBoiron8645f130-6a19-ae73-e053-2991aa0ab05b2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645eb60-65d1-9d6c-e053-2991aa0a94ef2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0e6-5c06-e053-2a91aa0ae83d2023-01-23Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466614-b8ee-2335-e053-2a91aa0aa67c2023-01-23Exact identifier
unii: 451W47IQ8X
Allium cepaONIONBoiron84ed787f-b68c-3aba-e053-2a91aa0a23432023-01-20Exact identifier
unii: 492225Q21H
Allium cepaONIONBoiron84edc238-e31f-071b-e053-2a91aa0a1cf22023-01-20Exact identifier
unii: 492225Q21H
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b6e6b8-27df-3503-e053-2a91aa0a525b2023-01-20Exact identifier
unii: 1MBW07J51Q
Hepar sulphuris calcareumCALCIUM SULFIDEBoiron85b666ab-8326-65c1-e053-2991aa0a74272023-01-20Exact identifier
unii: 1MBW07J51Q
Hydrastis candadensisGOLDENSEALBoiron85b973a2-ca44-1384-e053-2991aa0ab2602023-01-20Exact identifier
unii: ZW3Z11D0JV
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: ZW3Z11D0JV
PulsatillaANEMONE PULSATILLABoiron86a868c9-88ab-1469-e053-2a91aa0ae7452023-01-12Exact identifier
unii: I76KB35JEV
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
SOMCUPINSILVER NITRATE, SODIUM TETRACHLOROAURATE, ARABICA COFFEE BEAN, DELPHINIUM STAPHISAGRIA SEED, LACTUCA VIROSA, ZINC VALERATE DIHYDRATE, ESCHSCHOLZIA CALIFORNICA FLOWERING TOP, AND AVENA SATIVA FLOWERING TOPPEKANA Naturheilmittel GmbH76e887bb-6908-45bf-8b2e-cad5f50d2d242023-01-11WarningsExact identifier
unii: 3SW678MX72
OPSONATSILVER NITRATE, SULFURIC ACID, BELLIS PERENNIS, LYTTA VESICATORIA, GRATIOLA OFFICINALIS, GOLDENSEAL, LACHESIS MUTA VENOM, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbH506f8227-207c-462c-a71c-5f8f00b4f8de2023-01-11WarningsExact identifier
unii: ZW3Z11D0JV
coro-CALMACONITUM NAPELLUS, SELENICEREUS GRANDIFLORUS WHOLE, ARABICA COFFEE BEAN, LOBELIA INFLATA, FERULA SUMBUL ROOT, CONVALLARIA MAJALIS FLOWERING TOP, PRUNUS LAUROCERASUS LEAF, AND LEONURUS CARDIACA FLOWERING TOPPEKANA Naturheilmittel GmbHb41e84c1-a522-43e5-96f9-0f6bf90fc42d2023-01-11WarningsExact identifier
unii: 3SW678MX72
MUCANAMANITA MUSCARIA FRUITING BODY, GARLIC, ARISTOLOCHIA CLEMATITIS WHOLE, SIMABA CEDRON SEED, GOLDENSEAL, OKOUBAKA AUBREVILLEI BARK, AND VINCETOXICUM HIRUNDINARIA LEAFPEKANA Naturheilmittel GmbH199f200e-b2ee-4558-987a-43cacb3c6b6f2023-01-11WarningsExact identifier
unii: ZW3Z11D0JV
GLUCOREKTLACTIC ACID, DL-, SULFURIC ACID, ONION, CHIONANTHUS VIRGINICUS BARK, PHOSPHORUS, ZINC SULFATE HEPTAHYDRATE, CORN SILK, AND SYZYGIUM CUMINI FRUITPEKANA Naturheilmittel GmbH86293764-46a8-455a-8cba-7b4b3e1273872023-01-11WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
TOXEXSILVER NITRATE, BRYONIA DIOICA ROOT, CLEMATIS RECTA FLOWERING TOP, GOLDENSEAL, ECHINACEA, UNSPECIFIED, GALIUM APARINE, GLECHOMA HEDERACEA FLOWERING TOP, AND RHODODENDRON TOMENTOSUM LEAFY TWIGPEKANA Naturheilmittel GmbHd3ea4a0c-7692-44c4-a53d-af02ea116ef82023-01-11WarningsExact identifier
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

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