FDA.reportPublic FDA data

NDC 0025-1451-20 - Cytotec

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
0025-1451
Requested NDC
0025-1451-20
Package NDCs from labels
0025-1451-60, 0025-1451-20
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Effective date
2026-06-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cytotec - Pfizer Laboratories Div Pfizer IncPfizer Laboratories Div Pfizer Inc2026-06-04HUMAN PRESCRIPTION DRUG LABEL
Cytotec ® misoprostol tabletsPD-Rx Pharmaceuticals, Inc.2022-03-01HUMAN PRESCRIPTION DRUG LABEL
Cytotec - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-05-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-1451-34Cytotec100 in 1 CARTONTABLET10021
0025-1451-34Cytotec1 in 1 BLISTER PACKTABLET121
0025-1451-60Cytotec60 in 1 BOTTLE, UNIT-DOSETABLET6021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-1451CYTOTEC (MISOPROSTOL) TABLET [PFIZER LABORATORIES DIV PFIZER INC]19Current NDC, Legacy NDC, 3 package rows20250221_4ab12da7-5731-4e06-bf1c-bc3f2e711f12.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-1451-20EA - Each0025-145168ec755d-3886-4f22-a560-86527e6cf6c112012-07-24
0025-1451-34EA - Each0025-14510706fdf8-89e3-454b-a9df-f9de4d9d5f8412012-07-24
0025-1451-60EA - Each0025-1451481d9884-1a5b-4d01-80e4-058d3ffa073e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
misoprostolACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]4
misoprostolACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]4
hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [PD-RX PHARMACEUTICALS, INC.]4
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [PHYSICIANS TOTAL CARE, INC.]1

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 · 76 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
rxcui: 311727
rxcui: 317128
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
ndc (package): 0025-1461-60
ndc (package): 0025-1461-34
ndc (package): 0025-1451-60
ndc (package): 0025-1461-31
ndc (product): 0025-1451
ndc (product): 0025-1461
rxcui: 311727
rxcui: 209177
rxcui: 104098
rxcui: 317128
spl id: 35b84693-8a34-4008-831d-cd1df3724343
spl set id: 4ab12da7-5731-4e06-bf1c-bc3f2e711f12
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.