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 28 of 119 · 2,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
unii: PDC6A3C0OX
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.1352eff6-8b9e-473d-9acf-c0086e1d09172026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.56ee0bc8-c58e-4365-86e6-cb7211fe34132026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE AND SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.ebd8d6a4-ecd8-402e-b0b7-ceb9047c83d42026-01-08Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: C88X29Y479
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
unii: H0G9379FGK
POP Detox 6045POP DETOXProfessional Complementary Health Formulas48e7e23a-014c-4259-a2c9-37127da3ba032026-01-08WarningsExact identifier
unii: C88X29Y479
Skin Balance Liquescence 3027SKIN BALANCE LIQUESCENCEProfessional Complementary Health Formulasc644d8a4-de14-4583-9cc7-afaa0b3901222026-01-08WarningsExact identifier
unii: 70FD1KFU70
Flu Immune Drops 2145FLU IMMUNE DROPSProfessional Complementary Health Formulasb9cb50f7-0442-4f8a-a2e9-72b7a62c61862026-01-08WarningsExact identifier
unii: 70FD1KFU70
Carcinosin Miasm Drops 2142CARCINOSIN MIASM DROPSProfessional Complementary Health Formulasd6d1c012-1b72-499c-b736-5e0d8e0b0df72026-01-08WarningsExact identifier
unii: 70FD1KFU70
Toxagent Detox 6035TOXAGENT DETOXProfessional Complementary Health Formulase1476ce1-32ff-4c25-a330-dc78908f55912026-01-08WarningsExact identifier
unii: 70FD1KFU70
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: C88X29Y479
Learning Disability Drops 2040LEARNING DISABILITY DROPSProfessional Complementary Health Formulasc87531e6-4647-4127-a6ce-20ac296063cb2026-01-08WarningsExact identifier
unii: C88X29Y479
Pituitary/Pancreas/Kidney Drops 5033PITUITARY/PANCREAS/KIDNEY DROPSProfessional Complementary Health Formulas39ec853e-a63c-47b8-90dc-b006875d854f2026-01-08WarningsExact identifier
unii: C88X29Y479
Lycopodium Combination 9231LYCOPODIUM COMBINATIONProfessional Complementary Health Formulas0403922e-dce1-4925-8877-d6b765f7fc182026-01-08WarningsExact identifier
unii: C88X29Y479
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 70FD1KFU70
Kidney Stone Drops 2039KIDNEY STONE DROPSProfessional Complementary Health Formulas81579a5b-3e1d-452e-8e96-e4b4b500851a2026-01-08WarningsExact identifier
unii: C88X29Y479

Reported adverse events (FAERS/openFDA)#

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