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 77 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RexallEar Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURDolgencorp LLC59cfc7b4-faf0-4794-8911-d8745e12c6b82025-02-28WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Top Care Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURTopco Associates LLC2e8422f3-546a-4d09-84c0-4aa809ceaa622025-02-28WarningsExact identifier
unii: 70FD1KFU70
Equaline Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURUnited Natural Foods, Inc.1178cdcf-860d-42b7-974f-346485311a2f2025-02-28WarningsExact identifier
unii: 70FD1KFU70
Meijer Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURMeijer Distribution Inc8ff0fa61-964e-77a8-e053-2a95a90a2d3a2025-02-28WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Earache ReliefCHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHURSimilasan AGb9749db9-a2e4-4460-8769-6150285a74132025-02-28WarningsExact identifier
unii: 70FD1KFU70
Detoxify Facial MaskSULFURPrivate Label Skin Care4d023509-e430-4ebc-8fe7-87e638f49cbe2025-02-27WarningsExact identifier
unii: 70FD1KFU70
PlexionSULFACETAMIDE SODIUM, SULFURCintex Services, LLC2f11178a-fe6e-e45a-e063-6294a90aa3732025-02-26Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC2f1164ed-11c0-5646-e063-6394a90aace82025-02-26Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURCintex Services, LLC2f118cd1-f477-25e6-e063-6294a90a16622025-02-26Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Genexa Jet LagARNICA MONTANA, CINCHONA OFFICINALIS, COCCULUS INDICUS, COFFEA CRUDA, TABACUMGenexa Inc.d1262318-0a97-bf90-e053-2995a90a16a72025-02-26WarningsExact identifier
unii: 3SW678MX72
Genexa Kids SleepologyALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALISGenexa Inc.ba0cd3c2-9883-9664-e053-2995a90a9fd42025-02-26WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
Bestmade Natural Products BM197RHUS TOX, BRYONIA, COLOCYNTHIS, ARSENICUM ALBUM, HYPERICUM, CHAMOMILLA, GNAPHALLIUMBestmade Natural Products2ef5a641-e45a-bafc-e063-6394a90a1b5d2025-02-25WarningsExact identifier
unii: G0R4UBI2ZZ
Bestmade Natural Products BM201ARS ALB, BRYONIA, CHAMOMILLA, COLOCYNTHIS, NUX VOMICA, RHUS TOXBestmade Natural Products2ef7632e-dc8a-6b21-e063-6294a90ac2dd2025-02-25WarningsExact identifier
unii: G0R4UBI2ZZ
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Terramed Just Think Comfort Yeast reliefOLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALISRida LLC6112e199-b7dd-42e1-9004-f07a9bcd221d2025-02-25WarningsExact identifier
unii: ZW3Z11D0JV
Bestmade Natural Products BM190AVENA SATIVA, COFFEA CRUDA, HUMULUS LUP, IGNATIA AMARA, PASSIFLORA, VALERIANABestmade Natural Products2ea756c0-eb92-bb54-e063-6394a90a62062025-02-21WarningsExact identifier
unii: 3SW678MX72
Bestmade Natural Products BM191KREOSOTUM, NITRIC ACID, SULPHUR, SULPHURIC ACID, URTICA URENBestmade Natural Products2ea7c2e5-73d6-6820-e063-6294a90aaf1c2025-02-21WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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