FDA.reportPublic FDA data

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 1 of 114 · 2,276 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
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
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
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
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
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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