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 26 of 119 · 2,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pulsatilla Combination 9238PULSATILLA COMBINATIONProfessional Complementary Health Formulasaee2e5f5-8171-4a1a-8ea0-5d78ec22c8a82026-01-08WarningsExact identifier
unii: C88X29Y479
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: C88X29Y479
Attention Deficit Mild Drops 2146ATTENTION DEFICIT MILD DROPSProfessional Complementary Health Formulas68a65713-da9c-4f13-bc84-e45344b9dc642026-01-08WarningsExact identifier
unii: C88X29Y479
Renal Drops 5024RENAL DROPSProfessional Complementary Health Formulase598ae46-3b14-4dce-b7e0-abf159d102db2026-01-08WarningsExact identifier
unii: C88X29Y479
Fungus Nosode Combination 9401FUNGUS NOSODE COMBINATIONProfessional Complementary Health Formulasf85fb1bb-a395-45b8-9926-f652919a38302026-01-08WarningsExact identifier
unii: 70FD1KFU70
Sulphur 7138SULPHURProfessional Complementary Health Formulasce520b78-adda-4343-91c0-80d29912db552026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: 70FD1KFU70
Wet Eczema Drops 2136WET ECZEMA DROPSProfessional Complementary Health Formulas28f08a29-9b1a-4579-a56f-4cab7cdcfcb62026-01-08WarningsExact identifier
unii: 70FD1KFU70
Liver/Gallbladder Drops 5012LIVER/GALLBLADDER DROPSProfessional Complementary Health Formulas1d494c3c-517a-46de-84ca-65a0f4c60ee02026-01-08WarningsExact identifier
unii: C88X29Y479
Lachesis Combination 9229LACHESIS COMBINATIONProfessional Complementary Health Formulas7301c44c-2460-43ad-9cb2-dffdc8ee423c2026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Large Intestine 7004RET LARGE INTESTINEProfessional Complementary Health Formulasf1d07d3b-be59-4021-a9cb-8cb9b5b2aff52026-01-08WarningsExact identifier
unii: C88X29Y479
Energy Regulation Combination 9308ENERGY REGULATION COMBINATIONProfessional Complementary Health Formulasb091febb-f18f-46d1-8bb8-d911de4c89352026-01-08WarningsExact identifier
unii: 70FD1KFU70
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: C88X29Y479
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: C88X29Y479
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: 70FD1KFU70
Male Balance Liquescence 3034MALE BALANCE LIQUESCENCEProfessional Complementary Health Formulas8e0eb969-d946-469e-b2af-375eb5ad931e2026-01-08WarningsExact identifier
unii: C88X29Y479
Lycopodium clavatum 7126LYCOPODIUM CLAVATUMProfessional Complementary Health Formulas184c010f-becc-40bf-8c68-e15e873894c52026-01-08WarningsExact identifier
unii: C88X29Y479
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 70FD1KFU70
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: 70FD1KFU70
Bio ImmuneCHELIDONIUM MAJUS, LOBELIA INFLATA, RUMEX CRISPUS, SAMBUCUS NIGRA, SENEGA OFFICINALIS, SPONGIA TOSTA, TARAXACUM OFFICINALE, MYRISTICA SEBIFERA, STICTA PULMONARIA, SULPHUR, USTILAGO MAIDIS, POLYPORUS OFFICINALIS, CANDIDA ALBICANS, CARDUUS MARIANUS, CROTALUS HORRIDUS, SCROPHULARIA NODOSA, AGARICUS MUSCARIUS, BOVISTA, SECALE CORNUTUM, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTHRACINUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS VULGARIS, BOTULINUM, BRYONIA (ALBA), CAMPHORA, CINCHONA OFFICINALIS,Energique, Inc.fc837264-8edd-4234-a4c7-d699fcf1b8a02026-01-08WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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