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 38 of 175 · 3,493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Rheum Combination 9240RHEUM COMBINATIONProfessional Complementary Health Formulasf65a41b7-5931-4c62-89a3-7b255757527f2026-01-08WarningsExact identifier
unii: 269XH13919
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: 269XH13919
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
unii: 451W47IQ8X
Simple Chlorinated Combination 9315SIMPLE CHLORINATED COMBINATIONProfessional Complementary Health Formulasc1ab9a34-8a22-4840-ab8b-ef666dca155a2026-01-08WarningsExact identifier
unii: 269XH13919
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: 269XH13919
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: 269XH13919
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
unii: 269XH13919
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
Sciatica Drops 2059SCIATICA DROPSProfessional Complementary Health Formulasbced3ea7-18fb-41eb-bc41-ac043cf4b02f2026-01-08WarningsExact identifier
unii: 269XH13919
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70
RET Kidney 7005RET KIDNEYProfessional Complementary Health Formulas017f4c37-3eec-4078-9ce6-aca52fd4974d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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