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 35 of 119 · 2,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
unii: PDC6A3C0OX
Assorted Fruit Antacid ChewsCALCIUM CARBONATETarget Corporation40cd0ff8-c745-3b99-e054-00144ff88e882025-12-20WarningsExact identifier
unii: H0G9379FGK
Target Antacid Fruit ChewsCALCIUM CARBONATETarget964c07b7-4560-537c-e053-2995a90a2f4e2025-12-20WarningsExact identifier
unii: H0G9379FGK
Target Antacid - Anti-Gas Relief ChewsCALCIUM CARBONATETarget964e357c-a8ab-09fa-e053-2a95a90a37c62025-12-20WarningsExact identifier
unii: H0G9379FGK
Target Wild Berry Antacid Chews 60ctCALCIUM CARBONATETargetd8288751-f316-1dc0-e053-2995a90a139f2025-12-20WarningsExact identifier
unii: H0G9379FGK
Target Berry Lime HBG ChewsCALCIUM CARBONATETarget11fba65d-8a81-1227-e063-6294a90a11bd2025-12-20WarningsExact identifier
unii: H0G9379FGK
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
unii: H0G9379FGK
TopCare Cherry Antacid Soft ChewsCALCIUM CARBONATETopCodd93d53d-545a-b47c-e053-2a95a90a2a052025-12-20WarningsExact identifier
unii: H0G9379FGK
Kids Cold and Cough DaytimeCALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDEHyland's Consumer Health Inc.e6118c79-b6d5-5c09-e053-2a95a90a30cf2025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 Kids Cold and Cough DaytimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.804e0e7a-20eb-128b-e053-2991aa0aa82c2025-12-19WarningsExact identifier
unii: 70FD1KFU70
4 Kids Cold and Cough Nighttime Natural Grape FlavorONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEANHyland's Inc.7923e59a-f62c-44df-e053-2991aa0afc1e2025-12-19WarningsExact identifier
unii: 70FD1KFU70
GUN POWDERPOTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFURBoiron4653cf42-f61a-31a9-e063-6394a90a00a82025-12-19WarningsExact identifier
unii: 70FD1KFU70
Ultra Strength Antacid Tropical Fruit FlavorCALCIUM CARBONATE7-ELEVEN2f3c61ef-06a3-8a96-e063-6294a90ab8d22025-12-19WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Antacid Tropical Fruit FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2f3c3c65-4177-6304-e063-6294a90a51fa2025-12-19WarningsExact identifier
unii: H0G9379FGK
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Cherry Antacid Relief ChewCALCIUM CARBONATERite Aid6417a5d4-cfc9-b701-e053-2a91aa0a55cd2025-12-19WarningsExact identifier
unii: H0G9379FGK
Rite Aid Wild Berry Antacid ChewsCALCIUM CARBONATERite Aiddeac0759-86b9-6214-e053-2a95a90aa4c42025-12-19WarningsExact identifier
unii: H0G9379FGK
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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