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 33 of 175 · 3,493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Causticum Combination 9253CAUSTICUM COMBINATIONProfessional Complementary Health Formulas82b1a723-63e6-41b4-9940-a984dd719c872026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Pancreas DB Liquescence 3037PANCREAS DB LIQUESCENCEProfessional Complementary Health Formulas30bc86e9-538b-449a-af48-99aafc4059242026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Hypothalamus/Adrenal/Pituitary Drops 5032HYPOTHALAMUS/ADRENAL/PITUITARY DROPSProfessional Complementary Health Formulasf795b0b0-d4f9-447a-9d94-33daa3eef8e82026-01-08WarningsExact identifier
unii: 27YLU75U4W
Hyperthyroid Drops 2029HYPERTHYROID DROPSProfessional Complementary Health Formulasbe6f64dd-946b-4933-abb7-7b4c095c24902026-01-08WarningsExact identifier
unii: 27YLU75U4W
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Nux vomica 7129NUX VOMICAProfessional Complementary Health Formulas3bf25753-0e6d-444e-aa0a-a37fa55d7adb2026-01-08WarningsExact identifier
unii: 269XH13919
Staph/Strep/Respiratory Nosode Combination 9418STAPH/STREP/RESPIRATORY NOSODE COMBINATIONProfessional Complementary Health Formulas9981ec07-9bda-4789-9061-9e89de9ee8ed2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Degex Liquescence 3025DEGEX LIQUESCENCEProfessional Complementary Health Formulasb7697e21-3e5e-4a64-b557-8c186d5950db2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Genital Nosode Combination 9406GENITAL NOSODE COMBINATIONProfessional Complementary Health Formulas7acd5972-e8cc-4113-b719-587b5289487f2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Clematis Combination 9219CLEMATIS COMBINATIONProfessional Complementary Health Formulas95b41e24-6a9a-453a-a25c-abd7b4eba0842026-01-08WarningsExact identifier
unii: 27YLU75U4W
Blood Stim Liquescence 3004BLOOD STIM LIQUESCENCEProfessional Complementary Health Formulas24a47e6f-8b6d-4f42-b395-6cf116a8196f2026-01-08WarningsExact identifier
unii: 492225Q21H
C-Balance Liquescence 3022C-BALANCE LIQUESCENCEProfessional Complementary Health Formulase209f9bc-9d85-4ab7-8d41-187b65c548722026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Sabal Combination 9243SABAL COMBINATIONProfessional Complementary Health Formulas011790c2-5087-41da-9df7-3fd754b6c73c2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Soil/Water Contaminants Nosode Combination 9416SOIL/WATER CONTAMINANTS NOSODE COMBINATIONProfessional Complementary Health Formulas1a6eafda-8d03-49dc-8251-2ab08af641de2026-01-08WarningsExact identifier
unii: 269XH13919
Lymph/Spleen/Mammary Drops 5014LYMPH/SPLEEN/MAMMARY DROPSProfessional Complementary Health Formulasf2997062-d987-452e-8fc5-cf8f93279d362026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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