FDA.reportPublic FDA data

NDC 85534-0097-01 - Levofloxacin

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
85534-0097
Requested NDC
85534-0097-01
Package NDCs from labels
85534-0097-0, 85534-0097-1, 85534-0097-2, 85534-0097-3, 85534-0097-4, 85534-0097-5, 85534-0097-6, 85534-0097-01
Manufacturer
HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2026-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEMHAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-07-18HUMAN PRESCRIPTION DRUG LABEL

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 30 of 114 · 2,272 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: B697894SGQ
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
unii: B697894SGQ
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
unii: B697894SGQ
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: B697894SGQ
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: B697894SGQ
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
unii: B697894SGQ
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
unii: 15FIX9V2JP
LevofloxacinLEVOFLOXACINBPI LABS LLCb6d9740b-2f9d-4f1c-bc9b-4c2150b22f102025-12-26Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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