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 14 of 122 · 2,439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Matrix SupportCEANOTHUS AMERICANUS, ARGENTUM NITRICUM, CONDURANGO, HYDRASTIS CANADENSIS, MOMORDICA BALSAMINA, PULSATILLA (PRATENSIS), BILE DUCT (SUIS), COLON (SUIS), DUODENUM (SUIS), ESOPHAGUS (SUIS), EYE (SUIS), GALLBLADDER (SUIS), ILEUM (SUIS), INTESTINE (SUIS), IPECACUANHA, JEJUNUM (SUIS), KALI BICHROMICUM, LUNG (SUIS), MUCOSA NASALIS SUIS, NATRUM OXALACETICUM, ORAL MUCOSA (SUIS), PANCREAS SUIS, PHOSPHORUS, RECTAL MUCOSA (SUIS), STOMACH (SUIS), SULPHUR, VERATRUM ALBUM, MANNOSE, ANACARDIUM ORIENTALE, KREOSOTUM,Deseret Biologicals, Inc.bae2c721-44e8-4f88-92da-66e8ae03ada02026-05-06WarningsExact identifier
unii: 70FD1KFU70
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: C88X29Y479
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
unii: 70FD1KFU70
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
unii: 70FD1KFU70
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADERc7a8c877-3e20-4910-8ea4-1714fac3ff2f2026-05-04WarningsExact identifier
unii: H0G9379FGK
FolyraMULTIVITAMINOncora Pharma, LLCcb182e26-17c5-4d00-869f-08823afeeee82026-04-28Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Calcium CarbonateCALCIUM CARBONATECardinal Health 107, LLC8109dd2b-875c-40eb-82ac-d3780bc0c4372026-04-27WarningsExact identifier
unii: H0G9379FGK
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
unii: H0G9379FGK
Nut AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SULPHUR, ALMOND (NUT), CASHEW (NUT), BLACK WALNUT (NUT), PECAN (NUT), COCONUT, OLEUM OLEA EUROPAEA, CHESTNUT (NUT), WATER CHESTNUT (NUT), PINENUT (NUT), MACADAMIA (NUT), PISTACHIO (NUT), PEANUT (NUT), ENGLISH WALNUT (NUT), BRAZIL NUT (NUT), HAZELNUT (NUT), CARYA ALBABioActive Nutritional, Inc.fa2ac9d8-67e7-41b6-b57d-7b7cb29d05242026-04-23WarningsExact identifier
unii: 70FD1KFU70
unii: C88X29Y479
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: H0G9379FGK
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFURCintex Services, LLC50257047-1dc4-854d-e063-6394a90a50202026-04-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Dermveda SHINGLES RELIEFSULPHUR, CURCUMA LONGACelcius Corp.5901ce01-2215-499d-9374-0f09ced99b442026-04-21WarningsExact identifier
unii: 70FD1KFU70
LGB HPBELLADONNA, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), VERATRUM ALBUMBioActive Nutritional, Inc.4f6db767-4c5d-4f86-894d-99ff6db7c9202026-04-17WarningsExact identifier
unii: C88X29Y479
HepataforceCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUMBioActive Nutritional9ffe2336-6a38-405d-a6fd-cf39670039ff2026-04-17WarningsExact identifier
unii: C88X29Y479
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
unii: H0G9379FGK
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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