NDC 54973-4124-01 - Hylands Naturals Earache Drops

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
54973-4124
Requested NDC
54973-4124-01
Package NDCs from labels
54973-4124-1, 54973-4124-01
Manufacturer
Hyland's Inc.
Effective date
2026-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Earache DropsHyland's Inc.2026-08-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4124-1Hylands Naturals Earache Drops10 mL in 1 BOTTLE, DROPPERLIQUID106
54973-4124-1Hylands Naturals Earache Drops1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4124HYLANDS NATURALS EARACHE DROPS (BELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFUR) LIQUID [HYLAND'S INC.]3Current NDC, 2 package rows20250524_017ed754-9fe8-2cb5-e063-6294a90ab2f6.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 11 of 122 · 2,439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack2a8c6cc3-62b6-4682-9670-df9c0e6cb2e12026-06-12WarningsExact identifier
unii: 70FD1KFU70
BM BM193 DROPSAPIS MELL, ARS ALB, BERB VULG, HELLEBORE, LYCOPODIUMBM Private Limited540dd11f-e74f-b2f5-e063-6394a90af6e22026-06-12WarningsExact identifier
unii: C88X29Y479
BM BM10 DROPSACID PHOS, LYCOPODIUM, NAT SULPH, OPUNTIA VULG, SYZYGIUM JAMBOL, TARAXACUM, UVA URSITotal Operations Management LLC DBA:Bestmade Natural Products Micro540fdc6a-eda2-0daf-e063-6294a90a94522026-06-12WarningsExact identifier
unii: C88X29Y479
BM BM12 DROPSABIES NIGRA, ANTI CRUD, CONDURANGO, LYCOPODIUM, NUX VOM, ORNITHOGALUM, SYMPHYTUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro54101992-8836-568f-e063-6294a90add192026-06-12WarningsExact identifier
unii: C88X29Y479
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
unii: 70FD1KFU70
BM BM82 DROPSBETA VULG, BRYONIA, CALCAREA CARB, CAUSTICUM, HELLIBOR, IODIUM, LYCOPODIUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro54119432-912d-7ae1-e063-6294a90a850c2026-06-12WarningsExact identifier
unii: C88X29Y479
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.ea12ca3b-19e0-4d4a-9514-4d28d214e1e72026-06-12WarningsExact identifier
unii: 70FD1KFU70
unii: C88X29Y479
MICOXASPERGILLUS NIGER VAR. NIGER - CANDIDA ALBICANS - CENTELLA ASIATICA - MALIC ACID - MERCURIC CHLORIDE - RHIZOPUS STOLONIFER - SODIUM DIETHYL OXALACETATE - SULFUR - TABEBUIA IMPETIGINOSA BARK -Guna spa790b50d3-8e1e-4c36-be74-f30c51ca78952026-06-11WarningsExact identifier
unii: 70FD1KFU70
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: H0G9379FGK
unii: 2968PHW8QP
unii: 70FD1KFU70
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
unii: 70FD1KFU70
BM BM82 DROPSBETA VULG, BRYONIA, CALCAREA CARB, CAUSTICUM, HELLIBOR, IODIUM, LYCOPODIUMBM Private Limited5400ca1c-2a7f-0945-e063-6394a90aeeab2026-06-11WarningsExact identifier
unii: C88X29Y479
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: PDC6A3C0OX
BM BM10 DROPSACID PHOS, LYCOPODIUM, NAT SULPH, OPUNTIA VULG, SYZYGIUM JAMBOL, TARAXACUM, UVA URSIBM Private Limited53e79f25-2f58-85a2-e063-6294a90a6fa62026-06-10WarningsExact identifier
unii: C88X29Y479
BM BM12 DROPSABIES NIGRA, ANTI CRUD, CONDURANGO, LYCOPODIUM, NUX VOM, ORNITHOGALUM, SYMPHYTUMBM Private Limited53e81e3c-b83a-48dd-e063-6294a90a2c962026-06-10WarningsExact identifier
unii: C88X29Y479
GUNA-SLEEPAVENA SATIVA FLOWERING TOP - CANAKINUMAB - CHAMOMILE - HELLEBORUS NIGER ROOT - MELATONIN - MELISSA OFFICINALIS - PULSATILLA VULGARIS - SEROTONIN - STRYCHNOS IGNATII SEED - SUS SCROFA PINEAL GLAND - VALERIAN -Guna spa62c57cc4-28c9-406f-821d-1d48370968f22026-06-10WarningsExact identifier
unii: FGL3685T2X
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: H0G9379FGK
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
unii: H0G9379FGK
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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