FDA.reportPublic FDA data

NDC 54973-3243-01 - 4 KIDS COLD N COUGH 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
54973-3243
Requested NDC
54973-3243-01
Package NDCs from labels
54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4, 54973-3243-5, 54973-3243-01
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 Daytime 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
4 Kids Cold n Cough Day and Night Value PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2019-11-21HUMAN OTC DRUG LABEL
4 Kids Cold n Cough Day and Night Combo PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc.2016-06-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR118 mL in 1 BOTTLE, PLASTICLIQUID11817
54973-3243-14 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR236 mL in 1 BOTTLE, PLASTICLIQUID23617
54973-3243-24 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-34 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR1 in 1 CARTONLIQUID117
54973-3243-44 KIDS COLD N COUGH GRAPE FLAVOR148 mL in 1 BOTTLE, PLASTICLIQUID14817
54973-3243-54 KIDS COLD N COUGH GRAPE FLAVOR5 mL in 1 POUCHLIQUID517
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-32434 KIDS COLD N COUGH GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR) LIQUID [HYLAND'S INC.]15Current NDC, Legacy NDC, 8 package rows20240711_798e2a4d-da2d-4bbd-a9b8-574490ef7357.zip
54973-32434 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
54973-32434 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3243-1ML - Milliliter54973-32437d28e6b8-49a4-4b0d-a073-9caf269e10c612024-06-10

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 40 of 175 · 3,493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Circulation Drops 2013CIRCULATION DROPSProfessional Complementary Health Formulas377f4a5b-bcbb-47b7-b4f4-d198b98c84272026-01-08WarningsExact identifier
unii: 269XH13919
Industriox 6011INDUSTRIOXProfessional Complementary Health Formulasff4e04ce-6bff-419b-bb6b-d5e97b9942832026-01-08WarningsExact identifier
unii: 269XH13919
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
Uric Acid Combination 9307URIC ACID COMBINATIONProfessional Complementary Health Formulas3f136f86-a9ed-4a04-98cb-81abe33cd1812026-01-08WarningsExact identifier
unii: 269XH13919
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Chlorinated Ring Combination 9314CHLORINATED RING COMBINATIONProfessional Complementary Health Formulas2d75c97c-7b44-421a-b017-d011b3a316172026-01-08WarningsExact identifier
unii: 269XH13919
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 269XH13919
unii: 451W47IQ8X
unii: 1MBW07J51Q
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: 27YLU75U4W
Nitro-Thio Combination 9318NITRO-THIO COMBINATIONProfessional Complementary Health Formulas8ef8ac5a-df80-43a7-827d-de224a19beb92026-01-08WarningsExact identifier
unii: 269XH13919
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: 269XH13919
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: 269XH13919
unii: 70FD1KFU70
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Cough Drops 2014COUGH DROPSProfessional Complementary Health Formulas533c8124-d8bc-404a-9f1f-680d7ef8eb362026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Anti-Inflammation Drops 2005ANTI-INFLAMMATION DROPSProfessional Complementary Health Formulas66c901e0-9489-423b-98ef-c9fc517b5bd22026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Aesculus Combination 9202AESCULUS COMBINATIONProfessional Complementary Health Formulas5318d83a-2d8f-4ecc-80ac-d191be5f198f2026-01-08WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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