NDC 0555-9131-79 - OCELLA

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
0555-9131
Requested NDC
0555-9131-79
Package NDCs from labels
0555-9131-79, 0555-9131-67
Manufacturer
TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc.
Effective date
2026-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OCELLA - TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc.TEVA PHARMACEUTICALS USA, INC. | Bayer HealthCare Pharmaceuticals Inc.2026-03-04HUMAN PRESCRIPTION DRUG LABEL
OCELLA - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-07-03HUMAN PRESCRIPTION DRUG LABEL
OCELLA - Physicians Total Care, Inc. | Schering GmbH und Co. Produktions KGPhysicians Total Care, Inc. | Schering GmbH und Co. Produktions KG2011-02-23HUMAN 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
0555-9131-67OCELLA3 in 1 PACKAGEKIT328
0555-9131-79OCELLA1 in 1 BLISTER PACKKIT128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9131OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]24Legacy NDC, 2 package rows20241207_0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9131-67EA - Each0555-9131aa72b0e6-9f83-4ff7-b968-bf13300cd69d12012-07-24
0555-9131-79EA - Each0555-9131e64e1996-2a10-49e7-b0ba-3f674b8f3f7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
DROSPIRENONEACTIVE MOIETYN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
DROSPIRENONEACTIVE INGREDIENTN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
DROSPIRENONEACTIVE MOIETYN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOCELLA (DROSPIRENONE 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 114 · 2,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748800
rxcui: 748797
rxcui: 284207
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
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
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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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