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 17 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Sulfacetamide 9.8% Sulfur 4.8% CleanserSODIUM SULFACETAMIDE 9.8% SULFUR 4.8%Oncor Pharmaceuticals400646ae-94d1-4825-a737-161c4128e9d82026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% Sulfur 4% CLEANSERSODIUM SULFACETAMIDE AND SULFUROncor Pharmaceuticalsd44a7a26-ea6b-469f-931a-812a031868ea2026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 5% CleanserSODIUM SULFACETAMIDE 10% AND SULFUR 5%Oncor Pharmaceuticalsf5fecb2b-52d7-4373-b432-ad23aa93085e2026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
unii: 70FD1KFU70
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44eb8cf6-d8f0-0e08-e063-6394a90ac8ef2026-03-20WarningsExact identifier
unii: H0G9379FGK
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMBryant Ranch Prepack4ebfcaae-a375-45aa-a7f9-2b622f564f022026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Companyb94b16d3-b52f-4d70-bbb0-d9fb074c891c2026-03-19WarningsExact identifier
unii: H0G9379FGK
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5dbcde27-8c20-4ecc-81f7-117e0b0cadf32026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: C88X29Y479
Flu-ColdECHINACEA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, PHOSPHORUS, PYROGENIUM, RHUS TOXICODENDRONNatural Wonders46f674d1-8a50-4ebe-a0db-d539b75d91292026-03-19WarningsExact identifier
unii: C88X29Y479
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
unii: H0G9379FGK
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack25516616-2249-4b4f-be31-1a4378d038612026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackfb0c9508-0ff1-46eb-8df0-4bfd2c1231872026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5ddd93cf-cfeb-460c-b2c5-83f501ef9ab92026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
dermveda ULTRA EYE REMEDYSULPHUR, CURCUMA LONGACelcius Corp.1088f138-dacb-4a7b-a623-c49e41bccb672026-03-18WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lymph Tonic IIIADENOSINUM TRIPHOSPHORICUM DINATRUM, ARNICA MONTANA, BOLDO, CALCAREA IODATA, CALCAREA PHOSPHORICA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), GERMANIUM SESQUIOXIDE, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024-2025), NAJA TRIPUDIANS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SULPHUR, THYROIDINUM (SUIS), UBIDECARENONUMBioActive Nutritional, Inc.14f87aa6-2005-4939-a612-1162bbc5462b2026-03-18WarningsExact identifier
unii: 70FD1KFU70
Natural TestosteroneAVENA SATIVA. EPIMEDIUM, LYCOPODIUM CLAVATUM, DAMIANA, TESTOSTERONE, AGNUS CASTUSBioActive Nutritional, Inc.e2e6ce46-6729-4a63-90db-27e933379f452026-03-17WarningsExact identifier
unii: C88X29Y479
Naturasil Mite B Gone 5 oz 2 packSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.f12c4a7b-75ed-46e6-a0dd-b119538729c72026-03-17WarningsExact identifier
unii: 70FD1KFU70
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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