FDA.reportPublic FDA data

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 15 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: PDC6A3C0OX
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
unii: PDC6A3C0OX
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
unii: H0G9379FGK
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: PDC6A3C0OX
Easment Itch Defense Sulfur CreamSULFUR 1X HPUSEasment LLC4f140a93-dc32-0876-e063-6294a90a722a2026-04-09WarningsExact identifier
unii: 70FD1KFU70
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
dermveda SEBORRHEIC DERMATITISSULPHUR, CURCUMA LONGACelcius Corp.46c72658-5687-412a-99e7-3f6d040cb0c02026-04-09WarningsExact identifier
unii: 70FD1KFU70
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6ccc03bd-3f36-452a-8945-b3d71cce82412026-04-08WarningsExact identifier
unii: H0G9379FGK
dermveda FUNGAL ACNE RELIEFSULPHUR, CURCUMA LONGACelcius Corp.9505902d-b8c5-446e-a7da-822af6f900162026-04-08WarningsExact identifier
unii: 70FD1KFU70
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: C88X29Y479
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack7343904e-9fd0-473b-a8c0-b8fce48eea582026-04-07WarningsExact identifier
unii: 70FD1KFU70
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Lymphastat FECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, ABIES NIGRA, BORAX, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SEPIA, THUJA OCCIDENTALIS, SKATOLUM, CANDIDA ALBICANSEnergique, Ince23f7017-daf0-4dc3-99c4-9eabc217a8bc2026-04-02WarningsExact identifier
unii: C88X29Y479
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM (HUMAN), PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.004b278d-b129-416f-a8d4-1acad71338cf2026-04-02WarningsExact identifier
unii: C88X29Y479
DNA Pancreas FormulaLYCOPODIUM CLAVATUM, PANCREAS SUIS, DNA, INSULINUM, PHOSPHORICUM ACIDUM, RADIUM BROMATUM, URANIUM NITRICUMNutritional Specialties, Inc.dc0ddf27-5c97-4ec4-9032-ecaff0c8f5712026-04-02WarningsExact identifier
unii: C88X29Y479
Urinary HPBERBERIS VULGARIS, CANTHARIS, CAUSTICUM, CLEMATIS ERECTA, EQUISETUM HYEMALE, LAC CANINUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, PULSATILLA (PRATENSIS), SARSAPARILLA (SMILAX REGELII), SEPIA, STAPHYSAGRIAEnergique, Inc.e26bd66d-615a-47e5-a042-26bbafcd200e2026-04-02WarningsExact identifier
unii: C88X29Y479
Liver Gallbladder HPBELLADONNA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEPTANDRA VIRGINICA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PTELEA TRIFOLIATA, PULSATILLA (PRATENSIS), VERATRUM ALBUMEnergique, Inc.91f2500c-411f-4ef9-81f7-76e93d9bb3a52026-04-02WarningsExact identifier
unii: C88X29Y479

Reported adverse events (FAERS/openFDA)#

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