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 35 of 175 · 3,493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Liquescence 3031ALLERGY LIQUESCENCEProfessional Complementary Health Formulas3cd13971-86c3-404a-b9c8-108bbaec76d22026-01-08WarningsExact identifier
unii: 492225Q21H
unii: ZW3Z11D0JV
Phosphorus 7130PHOSPHORUSProfessional Complementary Health Formulasfa0761cc-b2e7-4528-9418-846bed165aa52026-01-08WarningsExact identifier
unii: 27YLU75U4W
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
Mer Detox 6019MER DETOXProfessional Complementary Health Formulas56b13bcb-150a-473a-b37a-60bdd2f65aa72026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 1MBW07J51Q
Tuberculinum Miasm Drops 2141TUBERCULINUM MIASM DROPSProfessional Complementary Health Formulasa03e89af-442d-47a2-97e6-a4af222021ac2026-01-08WarningsExact identifier
unii: 27YLU75U4W
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Glaucoma Drops 2074GLAUCOMA DROPSProfessional Complementary Health Formulas7cf2052e-15f8-4b04-ae18-1847da8f42362026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Skin Balance Liquescence 3027SKIN BALANCE LIQUESCENCEProfessional Complementary Health Formulasc644d8a4-de14-4583-9cc7-afaa0b3901222026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70
Flu Immune Drops 2145FLU IMMUNE DROPSProfessional Complementary Health Formulasb9cb50f7-0442-4f8a-a2e9-72b7a62c61862026-01-08WarningsExact identifier
unii: 70FD1KFU70
Carcinosin Miasm Drops 2142CARCINOSIN MIASM DROPSProfessional Complementary Health Formulasd6d1c012-1b72-499c-b736-5e0d8e0b0df72026-01-08WarningsExact identifier
unii: 70FD1KFU70
TMJ Drops 2154TMJ DROPSProfessional Complementary Health Formulasa937e0e7-899d-48db-af58-9e0c11d5a24c2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Insomnia Drops 2035INSOMNIA DROPSProfessional Complementary Health Formulas49dcc73f-2a20-4938-8671-0fa9dd39d5b82026-01-08WarningsExact identifier
unii: 3SW678MX72
Secale Combination 9244SECALE COMBINATIONProfessional Complementary Health Formulas6f68121f-48ac-478c-ad02-434db259920a2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: 492225Q21H
unii: 70FD1KFU70
Ulcer Drops 2094ULCER DROPSProfessional Complementary Health Formulas92cfc484-e3bc-4f04-a06a-3299c8522e322026-01-08WarningsExact identifier
unii: 2788Z9758H
unii: ZW3Z11D0JV
Learning Disability Drops 2040LEARNING DISABILITY DROPSProfessional Complementary Health Formulasc87531e6-4647-4127-a6ce-20ac296063cb2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: 269XH13919
Lycopodium Combination 9231LYCOPODIUM COMBINATIONProfessional Complementary Health Formulas0403922e-dce1-4925-8877-d6b765f7fc182026-01-08WarningsExact identifier
unii: 27YLU75U4W
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV

Reported adverse events (FAERS/openFDA)#

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