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 12 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
unii: 70FD1KFU70
Phosphorus 8PHOSPHORUS 8Uriel Pharmacy Inc.4efffc9a-f7ca-4b39-822d-e062f789dd192026-06-05WarningsExact identifier
unii: 27YLU75U4W
Insomnia HPARSENICUM ALBUM, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISBioActive Nutritional, Inc.cd17b39e-6531-407d-8007-8cb92a6e87442026-06-04WarningsExact identifier
unii: 3SW678MX72
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
Camilia BedtimeMATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, PHYTOLACCA AMERICANA ROOT, RHEUM OFFICINALE ROOTBoiron200c2af6-b457-b8bc-e063-6294a90a38002026-06-02Exact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackaaa87a7b-1ff7-43df-b82b-66dee775d8512026-06-01WarningsExact identifier
unii: 70FD1KFU70
ZicamALLIUM CEPA 5X, ZINCUM ACETICUM 2X, ZINCUM GLUCONIUM 1XChurch & Dwight Co., Inc.54604317-7d74-007e-e063-6394a90a5b832026-06-01WarningsExact identifier
unii: 492225Q21H
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackdafae162-9cae-4ba6-b8af-8c9bbc0f00102026-06-01WarningsExact identifier
unii: 70FD1KFU70
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
BM BM115 DROPSBORAX, CAPSICUM, CONDURANGO, HYDRASTIS CAN, KALI PERM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBM Private Limited532302ff-e18c-de15-e063-6394a90a2b1c2026-05-31WarningsExact identifier
unii: ZW3Z11D0JV
BM EGIOLAX PLUSALOES SOCO, BELLADONNA, BRYONIA ALBA, HYDRASTIS CAN, IPECAC, SENNA, CASCARA SAG, PHENOLPHTHALEIN POWDERBM Private Limited5323c1ff-7b44-dc7d-e063-6394a90ae6692026-05-31WarningsExact identifier
unii: ZW3Z11D0JV
BM HOMOEOLAXALOE SOCO, BRYONIA ALBA, CROTON TIG, HYDRASTIS CAN, ALUMEN, MAG MUR, PHENOLPHTHALEINBM Private Limited5324c47d-d085-dca0-e063-6394a90a92f92026-05-31WarningsExact identifier
unii: ZW3Z11D0JV
dermveda ULTRA FOLLICULITIS TREATMENTSULFUR, CURCUMA LONGACelcius Corp.f43bc300-50bf-421a-81f8-1da7fc829cd02026-05-29WarningsExact identifier
unii: 70FD1KFU70
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Genexa Kids Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.ae095073-27d1-0aa5-e053-2a95a90a86d42026-05-28WarningsExact identifier
unii: 492225Q21H
unii: G0R4UBI2ZZ
Naturasil Sulfur Lavender Multi-Purpose Relief 5 oz 2 pkSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.e033a4ae-245b-4abd-9975-f5358c2736a52026-05-28WarningsExact identifier
unii: 70FD1KFU70
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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