FDA.reportPublic FDA data

NDC 54973-3377-01 - 4 Kids Cold and Cough Nighttime Natural Grape Flavor

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
54973-3377
Requested NDC
54973-3377-01
Package NDCs from labels
54973-3377-1, 54973-3377-2, 54973-3377-3, 54973-3377-4, 54973-3377-01
Manufacturer
Hyland's Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Kids Cold & Cough Nighttime Natural Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
4 KIDS COLD N COUGH GRAPE FLAVOR - Hyland's Inc. | Applied Laboratories, IncHyland's Inc. | Applied Laboratories, Inc2025-02-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3377-14 Kids Cold and Cough Nighttime Natural Grape Flavor1 in 1 CARTONLIQUID113
54973-3377-14 Kids Cold and Cough Nighttime Natural Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID11813
54973-3377-24 Kids Cold and Cough Nighttime Natural Grape Flavor5 mL in 1 PACKETLIQUID513
54973-3377-34 Kids Cold and Cough Nighttime Natural Grape Flavor148 mL in 1 BOTTLE, PLASTICLIQUID14813
54973-3377-34 Kids Cold and Cough Nighttime Natural Grape Flavor1 in 1 CARTONLIQUID113
54973-3377-44 Kids Cold and Cough Nighttime Natural Grape Flavor5 mL in 1 POUCHLIQUID513
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33774 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) LIQUID [HYLAND'S INC.]10Current NDC, Legacy NDC, 6 package rows20230623_7923e59a-f62c-44df-e053-2991aa0afc1e.zip
54973-33774 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip
54973-33774 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]3Current NDC, Legacy NDC20250223_1a297e56-4cb8-75ca-e063-6294a90a592b.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 160 · 3,196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Female Formula 2068FEMALE FORMULAProfessional Complementary Health Formulase8d3990e-137c-4ae0-a702-7e50552c42942026-01-08WarningsExact identifier
unii: 2788Z9758H
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 1MBW07J51Q
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: 27YLU75U4W
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: 27YLU75U4W
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: 70FD1KFU70
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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