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 36 of 175 · 3,493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Digestive Stimulator Formula 2069DIGESTIVE STIMULATOR FORMULAProfessional Complementary Health Formulas1d3795d0-7d95-4b9c-b2fe-195460e645c82026-01-08WarningsExact identifier
unii: 2788Z9758H
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: 1MBW07J51Q
Digestive Enzyme Liquescence 3007DIGESTIVE ENZYME LIQUESCENCEProfessional Complementary Health Formulas74ce6879-ca7f-4664-949b-94abca92bc672026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 492225Q21H
Pain Formula IV Drops 2092PAIN FORMULA IV DROPSProfessional Complementary Health Formulas41e0eb72-7474-4d95-b316-6ffec7ffbfcd2026-01-08WarningsExact identifier
unii: 269XH13919
Small Joint Pain Drops 2038SMALL JOINT PAIN DROPSProfessional Complementary Health Formulasf6bf9ea0-61b3-4bfe-b167-0a0c146581672026-01-08WarningsExact identifier
unii: 269XH13919
Aralia Combination 9256ARALIA COMBINATIONProfessional Complementary Health Formulasc7248bb6-187d-4076-85dd-94753f7da3b52026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
RET Small Intestine 7010RET SMALL INTESTINEProfessional Complementary Health Formulas0be84681-1dd1-46bf-96ec-e7cde89ab31d2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Tinnitus Drops 2072TINNITUS DROPSProfessional Complementary Health Formulas24649b5b-ed21-4a32-8501-196b9e1348bb2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
unii: 70FD1KFU70
Mycobacter/Mycoplasma Nosode 4009MYCOBACTER/MYCOPLASMA NOSODEProfessional Complementary Health Formulas157e22fa-0791-4e8b-9d3a-7b6e94882c662026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70
Blood Clenz Drops 2012BLOOD CLENZ DROPSProfessional Complementary Health Formulas80a273da-bce5-4e37-89da-f40db0491e622026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70
Glyoxal Combination 9303GLYOXAL COMBINATIONProfessional Complementary Health Formulasb392b61f-9bfb-4296-b99d-41f1101d26e52026-01-08WarningsExact identifier
unii: 269XH13919
unii: 70FD1KFU70
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: 70FD1KFU70
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 269XH13919
unii: 451W47IQ8X
unii: 492225Q21H
Asthma Drops 2010ASTHMA DROPSProfessional Complementary Health Formulasb9f234ad-a5ff-40a9-bc51-c192f30140902026-01-08WarningsExact identifier
unii: 70FD1KFU70
Leptandra Combination 9230LEPTANDRA COMBINATIONProfessional Complementary Health Formulas2ce3a622-3d59-4a95-9dc2-22cd55b994a62026-01-08WarningsExact identifier
unii: 27YLU75U4W
Euphorbium Combination 9255EUPHORBIUM COMBINATIONProfessional Complementary Health Formulasff642588-439e-4e79-8c7b-3d388938eca52026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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