FDA.reportPublic FDA data

NDC 54973-4110-01 - Kids Cold and Cough Combo Pack

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
54973-4110
Requested NDC
54973-4110-01
Package NDCs from labels
54973-4110-1, 54973-4110-01
Manufacturer
Hyland's Consumer Health Inc. | 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 Naturals Kids Cold & Cough Combo Pack Grape FlavorHyland's Consumer Health Inc. | Hyland's Inc.2025-12-19HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold & Cough Daytime Grape FlavorHyland's Consumer Health Inc.2022-08-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4110-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4110-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3
54973-4110-1Kids Cold and Cough Daytime Grape Flavor1 in 1 CARTONLIQUID11
54973-4110-1Kids Cold and Cough Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4110KIDS COLD AND COUGH COMBO PACK (ONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFUR) KIT [HYLAND'S CONSUMER HEALTH INC.]2Current NDC, Legacy NDC20230927_e6ffd6d1-fcfb-547d-e053-2995a90af9b6.zip
54973-4110KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFUR) LIQUID [HYLAND'S CONSUMER HEALTH INC.]1Current NDC, Legacy NDC, 2 package rows20221201_e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d.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 6 of 162 · 3,235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mold AntigensARSENICUM ALBUM, HISTAMINUM HYDROCHLORICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALIS, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, RHIZOPUS NIGRICANSEnergique, Inc.881d9481-7c1f-45fc-a794-b7c43639daed2026-07-31WarningsExact identifier
unii: 27YLU75U4W
MUSCLE RESCUEARNICA MONTANA, RHUS TOX, PHYTOLACCA DECANDRA, PULSATILLA (VULGARIS), RUTA GRAVEOLENSPeaceful Mountain, Inc.69e74c40-7633-4935-a66a-e471324b66402026-07-30WarningsExact identifier
unii: I76KB35JEV
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
PancreaforceLAPPA MAJOR, RHAMNUS PURSHIANA, SYZYGIUM JAMBOLANUM, CHELIDONIUM MAJUS, JUNIPERUS VIRGINIANA, LYCOPODIUM CLAVATUM, MYRTUS COMMUNIS, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, TARENTULA CUBENSISBioActive Nutritional, Inc.0e067fba-762b-4897-8a2b-75d9b77242e32026-07-30WarningsExact identifier
unii: 27YLU75U4W
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
unii: 70FD1KFU70
OWELL NATURALS DRAW MAXAPIS MELLIFICA, CALENDULA OFFICINALIS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, LEDUM PALUSTRE, URTICA DIOICAOWELL NATURALS LLC57b30ce7-31c3-ed55-e063-6294a90a68f32026-07-28WarningsExact identifier
unii: 1MBW07J51Q
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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: 3SW678MX72
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: I76KB35JEV
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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