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 52 of 111 · 2,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyTerra Hand Sanitizer Foam NABENZALKONIUM CHLORIDEPortionPac Chemical Corporation207ed8a6-b8db-43c9-9335-b313b16af9d52025-09-17WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC190d7d61-5ea9-6670-e063-6294a90a45352025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC231ba8dd-e827-bc79-e063-6394a90a75382025-09-17WarningsExact identifier
unii: F5UM2KM3W7
I.C. Waterless Hand Cleaner with Micro ScrubbersBENZALKONIUM CHLORIDER & R Lotion, Inca0bcc8a1-8bc6-4a42-b12d-ea1f3d9977a62025-09-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideANTIBACTERIAL WET WIPESDiamond Wipes International9296f7ad-eab9-4336-b0fa-8297a070fd182025-09-11WarningsExact identifier
unii: F5UM2KM3W7
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
I.C. Antibacterial Hand CleanerBENZALKONIUM CHLORIDER & R Lotion, Incafd59808-4ab7-4752-b358-6b21b5d4ad302025-09-10WarningsExact identifier
unii: F5UM2KM3W7
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
I.C. Sanitizer and Re-Moisturizer with Benzalkonium ChlorideBENZALKONIUM CHLORIDER & R Lotion, Inccc5f24c8-fb85-49bd-8f55-4ec72fc0ffff2025-09-10WarningsExact identifier
unii: F5UM2KM3W7
Medi-First Plus Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLUnifirst First Aid Corporation57ea7f8a-26e2-367e-e053-2a91aa0a93e12025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationf2b7e1c4-6369-9efa-e053-2a95a90a82122025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB AntisepticBENZALKONIUM CHLORIDEEcolab Food Safety Specialties, Inc.933860e7-5a1f-453a-e053-2995a90a49022025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB Burn CreamBENZAALKONIUM CHLORIDE, LIDOCAINE HCLECOLAB Food Safety Specialties, Inc.4b2a7da9-c0e9-61c5-e054-00144ff8d46c2025-09-09WarningsExact identifier
unii: F5UM2KM3W7
ECOLAB AntisepticBENZALKONIUM CHLORIDE 0.13%ECOLAB Food Safety and Specialties, Inc.4c982e7b-2489-151f-e054-00144ff88e882025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Thompson AntisepticBENZALKONIUM CHLORIDEThompsonf537c81d-1fdc-3e0f-e053-2a95a90a6c2b2025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
unii: F5UM2KM3W7
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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