FDA.reportPublic FDA data

NDC 76420-438 - Tropicamide

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
76420-438
Package NDCs from labels
76420-438-15
Manufacturer
ASCLEMED USA INC.
Effective date
2025-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tropicamide Ophthalmic Solution, USP 1% Somerset Therapeutics, LLCASCLEMED USA INC.2025-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-438-15Tropicamide15 mL in 1 BOTTLESOLUTION/ DROPS151
76420-438-15Tropicamide1 in 1 CARTONSOLUTION/ DROPS11

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 111 · 2,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dalan Therapy Antibacterial Hand Wash, Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1e927-3b65-372e-e053-2a95a90accdc2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1fcab-9d55-4272-e053-2995a90a3bd02026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Dalan Therapy Antibacterial Hand Wash, Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1bbb2-18a3-2b00-e053-2995a90ace3c2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18ed1f-1428-49c9-e053-2a95a90ac4c82026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae1-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae5-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e0-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19269c-cd28-f12f-e053-2a95a90ab0162026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Liquid Hand Wash Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e2-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
unii: F5UM2KM3W7
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
unii: F5UM2KM3W7
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Walgreens Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Co.61aed8f1-ddf6-41d0-9d12-8affc43265d62026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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