FDA.reportPublic FDA data

NDC 54973-4059-01 - Kids Cough and Mucus Day and Night Grape

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
54973-4059
Requested NDC
54973-4059-01
Package NDCs from labels
54973-4059-1, 54973-4059-01
Manufacturer
Hyland's Inc.
Effective date
2025-06-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kids Cough & Mucus Combo Pack Daytime Nighttime Grape FlavorHyland's Inc.2025-06-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4056-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID12 [hp_X] in 1mL10
54973-4056-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4056-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID15 [hp_X] in 1mL10
54973-4057-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4059-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4059KIDS COUGH AND MUCUS DAY AND NIGHT GRAPE (RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATE) KIT [HYLAND'S INC.]9Current NDC, Legacy NDC, 7 package rows20250406_d92ab90b-b960-3df2-e053-2a95a90ace89.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 5 of 135 · 2,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Cough and Bronchial NighttimeACONITUM NAPELLUS, ALFALFA, ARABICA COFFEE BEAN, MEDICAGO SATIVA LEAF, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.31445469-8f7f-4729-8128-fc53d5e5ab062026-07-22WarningsExact identifier
unii: T7J046YI2B
unii: 1MBW07J51Q
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Pulsatilla 6XPULSATILLA VULGARISTrue Botanica, LLC3dead232-3110-e085-e063-6294a90a09262026-07-21WarningsExact identifier
unii: I76KB35JEV
Arnicare ArthritisARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAFLaboratoires Boironcb02378b-617d-4268-b565-4136e50009f42026-07-21Exact identifier
unii: T7J046YI2B
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: 1MBW07J51Q
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: G0R4UBI2ZZ
Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms ReliefOLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALISRida LLC5c42c8ae-3610-4fc9-b764-ccf22340d9ce2026-07-09WarningsExact identifier
unii: ZW3Z11D0JV
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Jacksons Cell Salts FERR PHOS 12X 4FERRUM PHOSZettl Health Inc.5647c1be-8727-36de-e063-6294a90a376a2026-07-07Exact identifier
unii: 91GQH8I5F7
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
BM BM18 DROPSBELLADONNA, BELLIS PER, EUPHRASIA, FERR PHOS, PASSIFLORA, PHYSOSTIGMA, RUTA GRAVEBM Private Limited55b745c6-42b6-da4e-e063-6394a90ad6272026-07-03WarningsExact identifier
unii: 91GQH8I5F7
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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