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 55 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hepar sulfuris SinusHEPAR SULFURIS SINUSUriel Pharmacy Inc.1066aef8-19cb-4b82-95e3-223efb87ce6d2025-11-06WarningsExact identifier
unii: 1MBW07J51Q
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
unii: PDC6A3C0OX
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Coffea crudaARABICA COFFEE BEANBoiron853d26eb-e3b8-4afa-e053-2a91aa0a85c32025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853da3cf-0727-a681-e053-2991aa0a67c92025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cdcd6-2dd3-8672-e053-2991aa0a55e02025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d031c-c242-bd6c-e053-2a91aa0ade262025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d2d9a-0c2c-22d0-e053-2a91aa0abaf82025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853dc617-a8b6-7626-e053-2a91aa0a9ec72025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d570d-59ca-7e1f-e053-2a91aa0a5f1f2025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cb3dd-773a-208c-e053-2a91aa0a61892025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron755c0d20-7a53-11e6-ad11-424c583030312025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cdfcd-6a94-3462-e053-2a91aa0a750e2025-11-05Exact identifier
unii: 3SW678MX72
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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