FDA.reportPublic FDA data

NDC 70000-0478-01 - LEADER Ear Drops for Swimmers

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
70000-0478
Requested NDC
70000-0478-01
Package NDCs from labels
70000-0478-1, 70000-0478-01
Manufacturer
Cardinal Health, 110 dba Leader | Pharma Nobis, LLC
Effective date
2023-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYCERIN - Cardinal Health, 110 dba Leader | Pharma Nobis, LLCCardinal Health, 110 dba Leader | Pharma Nobis, LLC2023-12-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0478-1LEADER Ear Drops for Swimmers30 mL in 1 CONTAINERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0478LEADER EAR DROPS FOR SWIMMERS LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20231223_874857eb-2a9d-6ef7-e053-2995a90af156.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0478-1ML - Milliliter70000-047883c23365-3366-4f3f-b091-b98993d934aa12020-08-06

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 4 of 53 · 1,050 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
application number: M014
rxcui: 631799
unii: PDC6A3C0OX
unii: ND2M416302
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
American Red Cross IPA 50% 6ozAMERICAN RED CROSS IPA 50% 6OZTSM BRANDS LLC29195bac-b096-ab8d-e063-6394a90a424a2026-07-01WarningsExact identifier
unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl AlcoholAMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAYMY IMPORTS USA LLC2929d580-cfff-e2b6-e063-6394a90a79aa2026-07-01WarningsExact identifier
unii: ND2M416302
McKesson Alcohol Prep PadISOPROPYL ALCOHOLMcKesson Medical-Surgicala8e759f3-91b1-44ae-960a-3a6cd4f746ce2026-06-30WarningsExact identifier
unii: ND2M416302
Tinted Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationf3c1c8a3-6b34-46cf-845e-c89db8f096f12026-06-30WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedical Chemical Corporationa04239d8-0fa9-4c00-aa81-d7a1242bc9312026-06-30WarningsExact identifier
unii: ND2M416302
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
rxcui: 631799
unii: ND2M416302
Lights Alcohol WipesISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.f9601021-4c52-4b48-96c1-b25fe8fef8b12026-06-26WarningsExact identifier
unii: ND2M416302
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
rxcui: 631799
unii: ND2M416302
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
Lights Medium AlcoholISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.873e0c9d-e0aa-44bb-a1f4-4474584790232026-06-25WarningsExact identifier
unii: ND2M416302
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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