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 36 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dry Eczema Drops 2006DRY ECZEMA DROPSProfessional Complementary Health Formulas72e775e7-e5fb-40fc-a96a-bc1b6015cc932026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Carduus Combination 9215CARDUUS COMBINATIONProfessional Complementary Health Formulasa244de13-836f-49b5-8c7a-d45bde704d782026-01-08WarningsExact identifier
unii: 70FD1KFU70
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Angina Drops 2083ANGINA DROPSProfessional Complementary Health Formulas99516597-9f59-4123-bd35-a4a73dd54d2d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Bacterial Immune Stimulator 6006BACTERIAL IMMUNE STIMULATORProfessional Complementary Health Formulas22f3b809-c294-4319-aed9-632f34608cbb2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
unii: 1MBW07J51Q
Terebinthina Combination 9248TEREBINTHINA COMBINATIONProfessional Complementary Health Formulas1363fff1-3b37-47d8-a17b-8bf8e72f66162026-01-08WarningsExact identifier
unii: 27YLU75U4W
RET Gallbladder 7007RET GALLBLADDERProfessional Complementary Health Formulas82bc7b50-aea3-4993-b171-919940fef2972026-01-08WarningsExact identifier
unii: 451W47IQ8X
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
unii: 451W47IQ8X
Food Poisoning Detox 6023FOOD POISONING DETOXProfessional Complementary Health Formulas76eff6d5-a8dc-4b06-91b7-fa0f1657df1a2026-01-08WarningsExact identifier
unii: 2788Z9758H
unii: ZW3Z11D0JV
Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: 3SW678MX72
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Sulphur Combination 9247SULPHUR COMBINATIONProfessional Complementary Health Formulasc9783fb0-399c-4f41-8c26-6f2d6534d3ef2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Nux Vomica Combination 9235NUX VOMICA COMBINATIONProfessional Complementary Health Formulas28f6663d-0a00-4650-a84e-b625024687d32026-01-08WarningsExact identifier
unii: 70FD1KFU70
Lyme Nosode Drops 2128LYME NOSODE DROPSProfessional Complementary Health Formulasc9fed770-938a-406b-ac95-593d1318ecce2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Perfumox 6028PERFUMOXProfessional Complementary Health Formulasd27ac082-12fc-477d-a5c0-bb74f29c0e602026-01-08WarningsExact identifier
unii: 27YLU75U4W
Sleep Disorder Drops 2152SLEEP DISORDER DROPSProfessional Complementary Health Formulas55af88df-8e5a-4e84-a8f6-fc3063d913812026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Kidney 7005RET KIDNEYProfessional Complementary Health Formulas017f4c37-3eec-4078-9ce6-aca52fd4974d2026-01-08WarningsExact identifier
unii: 27YLU75U4W

Reported adverse events (FAERS/openFDA)#

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