FDA.reportPublic FDA data

NDC 67046-1675-03 - Benztropine Mesylate

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
67046-1675
Requested NDC
67046-1675-03
Package NDCs from labels
67046-1675-3, 67046-1675-03
Manufacturer
Coupler LLC
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benztropine Mesylate - Coupler LLCCoupler LLC2026-05-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1675-3Benztropine Mesylate30 in 1 BLISTER PACKTABLET301

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 2 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATENavinta LLCf92fbafa-314d-4449-831f-26108339e6b22026-03-17Warnings, Adverse reactionsExact identifier
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 885219
unii: WMJ8TL7510
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 885213
rxcui: 885219
unii: WMJ8TL7510
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA040103
ndc (product): 50228-227
rxcui: 885213
rxcui: 885209
rxcui: 885219
spl id: 380cce0a-91d5-4c6e-80b0-e2b326264727
spl set id: 1ead16a7-88ed-407d-b25a-0d9a1d9da5ef
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885213
unii: WMJ8TL7510
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 885209
unii: WMJ8TL7510
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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