NDC 50458-251-00 - ORTHO TRI CYCLEN Lo

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
50458-251
Requested NDC
50458-251-00
Package NDCs from labels
50458-251-00, 50458-251-15, 50458-251-20, 50458-251-12
Manufacturer
Janssen Pharmaceuticals, Inc. | Janssen Ortho, LLC | Gedeon Richter Plc | Aspen Oss B.V.
Effective date
2021-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORTHO TRI CYCLEN LoJanssen Pharmaceuticals, Inc. | Janssen Ortho, LLC | Gedeon Richter Plc | Aspen Oss B.V.2021-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-251-00EA - Each50458-251399bee6f-7ca4-4eb2-bedd-b625789fd5b812013-09-04
50458-251-06EA - Each50458-2518b1f8c42-2575-4d8a-8b63-c41b5d1b176812018-03-08
50458-251-15EA - Each50458-251554d610a-f3ce-4aaa-9553-87ffd21cb4e312012-07-24
50458-251-28EA - Each50458-2518d381e6f-0cb7-4d74-911b-0ee39421bea712018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ethinyl estradiolACTIVE INGREDIENT423D2T571UORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
norgestimateACTIVE INGREDIENTC291HFX4DYORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
ethinyl estradiolACTIVE MOIETY423D2T571UORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
norgestimateACTIVE MOIETYC291HFX4DYORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Aluminum OxideINACTIVE INGREDIENTLMI26O6933ORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48ORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
HypromellosesINACTIVE INGREDIENT3NXW29V3WOORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
LactoseINACTIVE INGREDIENTJ2B2A4N98GORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30ORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990ORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Starch, CornINACTIVE INGREDIENTO8232NY3SJORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
TalcINACTIVE INGREDIENT7SEV7J4R1UORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6
WaterINACTIVE INGREDIENT059QF0KO0RORTHO TRI CYCLEN LO (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [JANSSEN PHARMACEUTICALS, INC.]6

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 123 · 2,459 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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