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 137 of 160 · 3,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RestSILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIANHyland's Inc.5e9924be-4dad-324a-e053-2a91aa0a8ec12022-12-13WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: G0R4UBI2ZZ
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 1MBW07J51Q
DEFEND SinusOYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, AND PULSATILLA VULGARISHyland's Inc.adc7a39f-555c-4d5a-8d88-6f4a491669822022-12-12WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
EARACHE DROPSBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFURHyland's Inc.9b18453e-e338-4b8e-9856-85aca8c46ee12022-12-12WarningsExact identifier
unii: 70FD1KFU70
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7611e508-6da2-3a2f-e053-2a91aa0a9f402022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDEBACTERIOSTATIC SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst763ff805-af1a-e8e9-e053-2a91aa0a82532022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2fae04e3-20b1-4b8c-b1fb-646b384836f12022-12-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.f48a35d4-aa0c-48b1-a2ad-a614ea2894e82022-12-07WarningsExact identifier
unii: G0R4UBI2ZZ
apo-PULMONION, BRYONIA DIOICA ROOT, HEDERA HELIX FLOWERING TWIG, HYOSCYAMUS NIGER, PHOSPHORUS, POLYGALA SENEGA ROOT, ANTIMONY POTASSIUM TARTRATE, AND PULMONARIA OFFICINALIS WHOLEPEKANA Naturheilmittel GmbH0bc9a4d1-2b10-444e-93f4-3836e48d60e02022-12-05WarningsExact identifier
unii: 27YLU75U4W
unii: 492225Q21H
ENT SupportPULSATILLA (PRATENSIS), EUPHORBIUM OFFICINARUM, LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2021-2022), SINUSITISINUM, ASPERGILLUS NIGER, CANDIDA ALBICANS, GALLICUM ACIDUM, MUCOR RACEMOSUS, MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.57067c80-d442-463a-babf-c5d3057cd9b42022-12-05WarningsExact identifier
unii: 1MBW07J51Q
apo-HEPATCHIONANTHUS VIRGINICUS BARK, IBERIS AMARA SEED, LYCOPODIUM CLAVATUM SPORE, MANDRAGORA OFFICINARUM ROOT, PHOSPHORUS, PEUMUS BOLDUS LEAF, CYNARA SCOLYMUS WHOLE, AND TARAXACUM OFFICINALE WHOLEPEKANA Naturheilmittel GmbH7ad32e27-b0a2-43e9-b306-2ebafc5adf832022-12-02WarningsExact identifier
unii: 27YLU75U4W
MET TOXARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRATWhite Manufacturing Inc. DBA Micro-West2653d62b-5dd7-482c-b31c-ce5fa13739002022-12-02WarningsExact identifier
unii: 451W47IQ8X
VIREXARSENICUM ALB, BAPTISIA, BELLADONNA, ECHINACEA, EUPATORIUM PERF, GELSEMIUM, LYCOPODIUM, , NUX VOM, PHOSPHORICUM AC, PHOSPHORUS, PYROGENIUM, RHUS TOXWhite Manufacturing Inc. DBA Micro-West77b9e94e-e159-4b77-bd8a-9f5937ac29062022-12-02WarningsExact identifier
unii: 27YLU75U4W
Whole System EepBELLADONNA, BERBER VULG, CAUSTICUM, CEANOTHUS, CHELIDONIUM MAJ, CINCHONA, COFFEA CRUDA, CONDURANGO, GRAPHITES, HYDRASTIS, IGNATIA, LILIUM, LYCOPODIUM, , MERC CORROS, NUX VOM, PANCREAS, SCROPHULARIA NODOSA, SENNA, SPONGIA, ZINC METWhite Manufacturing Inc. DBA Micro-Westccdee0bb-18cc-4180-ac4b-d9dc5c79895e2022-12-02WarningsExact identifier
unii: 3SW678MX72
unii: ZW3Z11D0JV
Miranda Castros Healing Gel for Bites and StingsCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS.OHM PHARMA INC.8e06aaa4-c177-45cf-9d8d-e0099de256682022-12-02WarningsExact identifier
unii: 451W47IQ8X
Yonis BlissCHAMOMILLA, NATRUM MURIATICUMBrookhaus Essentials LLCea4091d6-d295-41a0-aae5-68f3c260e1102022-11-30WarningsExact identifier
unii: 451W47IQ8X
unii: G0R4UBI2ZZ
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Cough HPARSENICUM ALBUM, BRYONIA ALBA, CUPRUM ACENTICUM, DROSERA ROTUNDIFOLIA, IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA, SPONGIA TOSTANatural Creations, Inc62ae8d8f-67c8-4347-b910-a173d8283b182022-11-23WarningsExact identifier
unii: 27YLU75U4W
unii: I76KB35JEV
Kids ReliefDROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEE CRUDEAHomeolab International (Canada) inccacffbb1-c872-46ea-add0-bc7261da32e72022-11-21WarningsExact identifier
unii: 3SW678MX72

Reported adverse events (FAERS/openFDA)#

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