FDA.reportPublic FDA data

NDC 69238-1581-03 - Zenchent FE

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
69238-1581
Requested NDC
69238-1581-03
Package NDCs from labels
69238-1581-3, 69238-1581-03
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2022-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zenchent FE - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2022-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1581-3Zenchent FE3 in 1 CARTONKIT37
69238-1581-3Zenchent FE1 in 1 BLISTER PACKKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1581ZENCHENT FE (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 2 package rows20231231_17a9750b-e1b0-4293-992d-195b2eb9ea11.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 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERREMEDYREPACK INC.5d67a268-437b-403d-9d05-6524c4a7c4992026-08-11WarningsExact identifier
unii: R5L488RY0Q
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Minovia MiniMINOVIA MINIOncora Pharma, LLC297673c1-23db-47b5-8cfb-aaecc07908382026-06-24Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: R5L488RY0Q

Reported adverse events (FAERS/openFDA)#

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