FDA.reportPublic FDA data

NDC 67296-1936-01 - misoprostol

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
67296-1936
Requested NDC
67296-1936-01
Package NDCs from labels
67296-1936-1, 67296-1936-01
Manufacturer
Redpharm Drug
Effective date
2025-12-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
misoprostol - Redpharm DrugRedpharm Drug2025-12-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1936-1misoprostol10 in 1 BOTTLETABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1936MISOPROSTOL TABLET [REDPHARM DRUG]1Current NDC, 1 package rows20250309_2fd197c6-05db-5011-e063-6294a90a585d.zip

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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
misoprostolMISOPROSTOLMylan Pharmaceuticals Inc.c4fe14fb-0a43-4c31-9cd6-29eb0d1567052026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
ndc (product): 59762-5008
rxcui: 311727
rxcui: 317128
spl id: a2441a04-9c20-452a-91e2-025ad1657568
spl set id: c4fe14fb-0a43-4c31-9cd6-29eb0d156705
unii: 0E43V0BB57
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
misoprostolMISOPROSTOLBryant Ranch Prepackc842c35f-6a64-4ecc-95a1-41b6d056047e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
rxcui: 311727
unii: 0E43V0BB57
MisoprostolMISOPROSTOLAmerican Health Packaging9462d969-d3e5-4e7f-b556-bd647ab28c422026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
MisoprostolMISOPROSTOLGenBioPro, Inc.21e20753-4a67-ce4e-e063-6394a90aa5982026-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317128
unii: 0E43V0BB57
CytotecMISOPROSTOLPfizer Laboratories Div Pfizer Inc4ab12da7-5731-4e06-bf1c-bc3f2e711f122026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA019268
rxcui: 311727
rxcui: 317128
unii: 0E43V0BB57
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
unii: ZF94AP8MEY
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepack6865a5cf-3263-44b5-96d9-7a7a4c6e1c052026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0E43V0BB57
MisoprostolMISOPROSTOLBryant Ranch Prepackc4668066-3d67-487d-9071-f1e504f664992026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311727
unii: 0E43V0BB57
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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