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 22 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMMethod Pharmaceuticals, LLCdfc5bab2-2170-606e-e053-2a95a90a39612026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
sulfacetamide sodium and sulfur Sodium Sulfacetamide - SulfurSULFACETAMIDE SODIUM AND SULFURAllegis Pharmaceuticals, LLC1aa1025f-c568-34d3-e063-6394a90a37b82026-02-11Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
dermveda NAIL FUNGUS SERUMOLIVE EXTRACT, SULFURCelcius Corp.6d999dac-7b84-4f19-957e-5c787a4e96c42026-02-09WarningsExact identifier
unii: 70FD1KFU70
Dermveda JOCK ITCHSULPHUR, CURCUMA LONGACelcius Corp.bb9c3941-a778-49ba-b58c-75ab5b93b3d02026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda PSORIASIS AND SEBORRHEIC DERMATITISSULFUR, CURCUMA LONGACelcius Corp.a05c1e45-ca2f-49a1-a3f9-32dc51278fb62026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda SCABIES ITCH RELIEF SERUMOLIVE EXTRACT, SULFURCelcius Corp.86a8bffd-81a8-4f22-89b6-e51158f336db2026-02-09WarningsExact identifier
unii: 70FD1KFU70
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: C88X29Y479
dermveda BORIC ACID BV, YEAST INFECTIONBORICUM ACIDUM, CHAMOMILLACelcius Corp.e4855b64-c462-46f3-8051-26da228ceaf82026-02-06WarningsExact identifier
unii: FGL3685T2X
dermveda JOCK ITCHOLIVE EXTRACT, SULFURCelcius Corp.252ed439-0e4c-419f-8b34-d1b52da8464f2026-02-06WarningsExact identifier
unii: 70FD1KFU70
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: H0G9379FGK
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: H0G9379FGK
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: H0G9379FGK
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: C88X29Y479
LEADER Ultra Strength Peppermint FlavorCHEWABLE ANTACID TABLETSCardinal Health3bf16b23-5a67-454f-b335-677cc49cd7a32026-02-02WarningsExact identifier
unii: H0G9379FGK
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: FGL3685T2X
Cough and Mucus NightANTIMONIUM TARTARICUM, AVENA SATIVA, BRYONIA (ALBA), CHAMOMILLA, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, STANNUM METALLICUM, SULPHURNaturalCaref27e3a7f-78a3-4003-95fc-0b32671df4432026-02-02WarningsExact identifier
unii: 70FD1KFU70
Tums Chewy Bites Raspberry LemonadeCALCIUM CARBONATEHaleon US Holdings LLC3a9b6838-d450-9c3c-e063-6294a90acb622026-02-02WarningsExact identifier
unii: H0G9379FGK
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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