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 37 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: 70FD1KFU70
Immune Enhancement Liquescence 3029IMMUNE ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas57cacb32-193b-4edf-a477-b6eb11a202832026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: 70FD1KFU70
Liver Stim Liquescence 3015LIVER STIM LIQUESCENCEProfessional Complementary Health Formulas59ccef5a-9e70-4e47-8cdf-dedc27dea51b2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Hemorrhoid Drops 2028HEMORRHOID DROPSProfessional Complementary Health Formulas0d484842-8358-426a-976a-28cdf24c8b682026-01-08WarningsExact identifier
unii: 70FD1KFU70
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pancreas Drops 5020PANCREAS DROPSProfessional Complementary Health Formulas669a47a1-ae68-4b49-9f21-288314e9eb762026-01-08WarningsExact identifier
unii: 2788Z9758H
Selenium Combination 9245SELENIUM COMBINATIONProfessional Complementary Health Formulas1c2cc0ad-f859-470b-be4b-f98e010a2e5c2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Pollinosis Combination 9261POLLINOSIS COMBINATIONProfessional Complementary Health Formulas2a4336d2-dcaa-4a15-95e5-b76c5646825a2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: 70FD1KFU70
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Consciousness Stim Formula 2099CONSCIOUSNESS STIM FORMULAProfessional Complementary Health Formulas210f3135-9492-4c1c-a438-b435b33df6df2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Graphites Combination 9225GRAPHITES COMBINATIONProfessional Complementary Health Formulas9ca4d6aa-e183-4400-b1e0-363cb26209aa2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Bryonia Combination 9212BRYONIA COMBINATIONProfessional Complementary Health Formulas36f8599e-8b35-4903-9731-dbcc2fa5092e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Calendula Combination 9260CALENDULA COMBINATIONProfessional Complementary Health Formulas0e0770d8-680a-471a-b496-7105631ca6f42026-01-08WarningsExact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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