FDA.reportPublic FDA data

NDC 50419-403-01 - Safyral

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
50419-403
Requested NDC
50419-403-01
Package NDCs from labels
50419-403-00, 50419-403-01, 50419-403-03, 50419-403-71, 50419-403-75, 50419-403-70
Manufacturer
Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG
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
Safyral - Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KGBayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG2026-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-403-00Safyral1 in 1 BLISTER PACKKIT123
50419-403-00Safyral90 in 1 PACKAGEKIT9023
50419-403-01Safyral1 in 1 BLISTER PACKKIT123
50419-403-03Safyral3 in 1 PACKAGEKIT323
50419-403-70Safyral90 in 1 PACKAGEKIT9023
50419-403-70Safyral1 in 1 BLISTER PACKKIT123
50419-403-71Safyral1 in 1 BLISTER PACKKIT123
50419-403-75Safyral12 in 1 CARTONKIT1223
50419-403-75Safyral5 in 1 PACKAGEKIT523

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-403SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 9 package rows20241122_97563516-306a-4e17-9690-edbda49ecd83.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-403-01EA - Each50419-403f821ffec-4a56-42c7-9143-b16e58f977b412016-02-04
50419-403-03EA - Each50419-4036c27e5cf-2277-47be-927b-cdc9597f83fc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571USAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
LEVOMEFOLATE CALCIUMACTIVE INGREDIENTA9R10K3F2FSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
DROSPIRENONEACTIVE MOIETYN295J34A25SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571USAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
LEVOMEFOLIC ACIDACTIVE MOIETY8S95DH25XCSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
BETADEXINACTIVE INGREDIENTJV039JZZ3ASAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1USAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]8

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 59 of 109 · 2,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
unii: 15FIX9V2JP
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
unii: 15FIX9V2JP
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
unii: 15FIX9V2JP
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
unii: 15FIX9V2JP
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
unii: 15FIX9V2JP
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
unii: 15FIX9V2JP
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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