FDA.reportPublic FDA data

NDC 51285-092-82 - LoSeasonique

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
51285-092
Requested NDC
51285-092-82
Package NDCs from labels
51285-092-82, 51285-092-87
Manufacturer
Teva Women's Health LLC
Effective date
2023-06-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LoSeasonique - Teva Women's Health LLCTeva Women's Health LLC2023-06-06HUMAN PRESCRIPTION DRUG LABEL
LoSeasonique - Physicians Total Care, Inc. | Teva Women's Health, Inc.Physicians Total Care, Inc. | Teva Women's Health, Inc.2012-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51285-092-87EA - Each51285-092d02831c3-b960-446c-9af6-1aabafaf620c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673LOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2

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 117 · 2,322 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
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
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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