FDA.reportPublic FDA data

NDC 54973-3379-01 - 4 Kids Cold and Cough Day and Night 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
54973-3379
Requested NDC
54973-3379-01
Package NDCs from labels
54973-3379-1, 54973-3379-01
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 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
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
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL11
54973-3379-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33794 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 NDC, 5 package rows20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.zip

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 32 of 160 · 3,196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Compulsive Eating Drops 2073COMPULSIVE EATING DROPSProfessional Complementary Health Formulasecc5e1b8-ba50-4aee-bccb-6798eefe95ea2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Rauwolfia Combination 9258RAUWOLFIA COMBINATIONProfessional Complementary Health Formulas938dd5da-74f4-4f2a-bfc1-e54163473dc72026-01-08WarningsExact identifier
unii: 70FD1KFU70
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 2788Z9758H
unii: 451W47IQ8X
Thyro Drops 5028THYRO DROPSProfessional Complementary Health Formulas531baa48-da8d-46f9-a614-69c98850dcae2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Avar-eSULFACETAMIDE SODIUM, SULFURMission Pharmacal Companyca31ab21-8db5-4a65-ab81-b141d350a1ce2026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
AVAR LSSULFACETAMIDE SODIUM, SULFURMission Pharmacal Company41b62ca7-f6de-4714-ae5b-a0e59d2ef4522026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
AVARSULFACETAMIDE SODIUM, SULFURMission Pharmacal Company88e4070f-0538-463d-b9a7-98a4e8979cd12026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
unii: PDC6A3C0OX
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.1352eff6-8b9e-473d-9acf-c0086e1d09172026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.56ee0bc8-c58e-4365-86e6-cb7211fe34132026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.ebd8d6a4-ecd8-402e-b0b7-ceb9047c83d42026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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