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 57 of 111 · 2,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 451W47IQ8X
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
bolor sanitizing hand wipesBOLOR SANITIZING HAND WIPESEcoRhine LLC357e2190-5c43-86ba-e063-6294a90a97e62025-06-29WarningsExact identifier
unii: F5UM2KM3W7
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
fomin mini Hand Sanitizer Wipes MELON POPBENZALKONIUM CHLORIDEFomin LLC080b6b55-ba4b-46a6-bcc2-914f906e05912025-06-24WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.38381a41-db33-45c6-e063-6394a90a23172025-06-23WarningsExact identifier
unii: F5UM2KM3W7
fomin mini Hand Sanitizer Wipes COCO-NILLA BLISSBENZALKONIUM CHLORIDEFomin LLC75a13584-a151-4fd4-a281-fec630801d652025-06-23WarningsExact identifier
unii: F5UM2KM3W7
fomin mini Hand Sanitizer Wipes FRAGRANCE FREEBENZALKONIUM CHLORIDEFomin LLC020f06c6-c76c-40fc-bc56-c11d5b389d672025-06-23WarningsExact identifier
unii: F5UM2KM3W7
Kindest Kare Advanced Antimicrobial Foam HandwashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.9ea1175e-45aa-45c5-87a1-55d64cc37a882025-06-20WarningsExact identifier
unii: F5UM2KM3W7
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Cart Wipes Clean Sanitizing WipesBENZALKONIUM CHLORIDECarts and Parts INC.6a8433e8-7b96-44ce-b8e2-c60575898dab2025-06-18WarningsExact identifier
unii: F5UM2KM3W7
FoamFresh Alco-Free Hand SanitizerBENZALKONIUM CHLORIDEWoodbine Products Company59614a1a-6b76-45e7-8b57-af307a1673cf2025-06-17WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP32bc07dc-7a9c-63ed-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP33376694-fccd-6ed5-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3337b028-2291-0a1d-e054-00144ff88e882025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3338023a-171e-1e49-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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