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 12 of 122 · 2,439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Calcium Carbonate 1000mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24ce4597-b571-3cbf-e063-6394a90a8ea22026-06-09WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: H0G9379FGK
HZ FormulaBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, SPLEEN (SUIS), THYMUS (SUIS), THROIDINUM (SUIS), GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, CHLAMYDIA TRACHOMATIS, HERPES SIMPLEX 1 NOSODE, HERPES SIMPLEX 2 NOSODE, CANDIDA ALBICANS, HUMAN PAPILLOMAVIRUS, TRICHINELLA SPIRALISBioActive Nutritional, Inc3929188d-99bc-497f-bac7-3493bd58d2f72026-06-08WarningsExact identifier
unii: C88X29Y479
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: FGL3685T2X
unii: C88X29Y479
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
unii: 70FD1KFU70
Pandanus Calc. carb.PANDANUS CALC. CARB.Uriel Pharmacy Inc.5affa022-7614-4ca9-8807-e26d7df56a6a2026-06-05WarningsExact identifier
unii: H0G9379FGK
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
VitaluxMULTIVITAMINPureTek Corporation52d5eee7-8146-cc62-e063-6394a90a8c3f2026-06-02Boxed warning, Adverse reactionsExact identifier
unii: H0G9379FGK
Antacid- Calcium CarbonateCALCIUM CARBONATEAnhui Jiuhe Health Industry Co., Ltd53518897-5387-38cf-e063-6394a90aa3e12026-06-02WarningsExact identifier
unii: H0G9379FGK
Good Neighbor Pharmacy Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerisource Bergenb7453c0e-b452-409b-a324-83fdd105bfd02026-06-02WarningsExact identifier
unii: H0G9379FGK
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackaaa87a7b-1ff7-43df-b82b-66dee775d8512026-06-01WarningsExact identifier
unii: 70FD1KFU70
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESavings Distributors LLC549136d5-8f2c-d417-e063-6394a90a23e42026-06-01WarningsExact identifier
unii: H0G9379FGK
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackdafae162-9cae-4ba6-b8af-8c9bbc0f00102026-06-01WarningsExact identifier
unii: 70FD1KFU70
Regular Strength Antacid PeppermintCALCIUM CARBONATEHyvee Inc4e5526a8-d9ad-965b-e063-6294a90a83332026-06-01WarningsExact identifier
unii: H0G9379FGK
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEMeijer Distribution Inc50fe57e1-6678-4697-9b35-4673db67d4fb2026-06-01WarningsExact identifier
unii: H0G9379FGK
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
dermveda ULTRA FOLLICULITIS TREATMENTSULFUR, CURCUMA LONGACelcius Corp.f43bc300-50bf-421a-81f8-1da7fc829cd02026-05-29WarningsExact identifier
unii: 70FD1KFU70
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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