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 3 of 122 · 2,439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
unii: H0G9379FGK
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
ndc (package): 54973-4124-1
ndc (product): 54973-4124
ndc11 (package): 54973412401
spl id: 59d42624-de71-d5fa-e063-6394a90a7363
spl set id: 017ed754-9fe8-2cb5-e063-6294a90ab2f6
unii: 4M1169RWJD
unii: H0G9379FGK
unii: FGL3685T2X
unii: 70FD1KFU70
unii: 6GZW20TIOI
unii: C88X29Y479
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
unii: H0G9379FGK
EdemaforceCACTUS GRANDIFLORUS, CALENDULA OFFICINALIS, DULCAMARA, LEPTANDRA VIRGINICA, SOLIDAGO VIRGAUREA, CONVALLARIA MAJALIS, APIS MELLIFICA, ARNICA MONTANA, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PLUMBUM METALLICUM, SAMBUCUS NIGRABioActive Nutritional, Inc.5e7d1909-932a-41a3-bad3-be320bb9ef352026-08-20WarningsExact identifier
unii: C88X29Y479
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: 70FD1KFU70
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: C88X29Y479
Naturasil Tinea Versicolor ReliefSULFURNature's Innovation, Inc.255f4fdb-bcc5-45e2-b9bd-06908bfbe23b2026-08-19WarningsExact identifier
unii: 70FD1KFU70
Anti-Itch CreamANTI-ITCH CREAMBuzzie LLC596d1aae-c97e-c928-e063-6394a90a77d92026-08-19WarningsExact identifier
unii: C88X29Y479
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: H0G9379FGK
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: H0G9379FGK
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
unii: H0G9379FGK
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM215 DROPSANTI CRUD, ARG NIT, CAJUPUT, CARBO VEG, LYCOPODIUM, NUX VOM, PULSATILLABM Private Limited590ab6cb-72be-cfde-e063-6394a90a65ac2026-08-14WarningsExact identifier
unii: C88X29Y479
BM BM220 DROPSBAPTISIA, CHAMOMILLA, CHINA OFF, COLOCYNTHIS, DULCAMARA, MERC DUL, PODOPHYLLUMBM Private Limited590adab5-9c66-e7e2-e063-6394a90a6b4c2026-08-14WarningsExact identifier
unii: FGL3685T2X
Travel Reset Jet Lag - Motion SicknessCHAMOMILLA 9C, COCCULUS INDICUS 9C, IGNATIA AMARA 9C, IPECACUANHA 9C, LYCOPODIUM CLAVATUM 9C, TABACUM 9CSEVENE USA5511dcde-f818-07c8-e063-6294a90aebfe2026-08-13WarningsExact identifier
unii: C88X29Y479

Reported adverse events (FAERS/openFDA)#

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