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
Label	Manufacturer	Effective date	Type
Safyral - Bayer HealthCare Pharmaceuticals Inc. \| Bayer Weimar GmbH und Co. KG	Bayer HealthCare Pharmaceuticals Inc. \| Bayer Weimar GmbH und Co. KG	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-403-00	Safyral	1 in 1 BLISTER PACK	KIT	1	23
50419-403-00	Safyral	90 in 1 PACKAGE	KIT	90	23
50419-403-01	Safyral	1 in 1 BLISTER PACK	KIT	1	23
50419-403-03	Safyral	3 in 1 PACKAGE	KIT	3	23
50419-403-70	Safyral	90 in 1 PACKAGE	KIT	90	23
50419-403-70	Safyral	1 in 1 BLISTER PACK	KIT	1	23
50419-403-71	Safyral	1 in 1 BLISTER PACK	KIT	1	23
50419-403-75	Safyral	12 in 1 CARTON	KIT	12	23
50419-403-75	Safyral	5 in 1 PACKAGE	KIT	5	23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-403	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 9 package rows	20241122_97563516-306a-4e17-9690-edbda49ecd83.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-403-01	EA - Each	50419-403	f821ffec-4a56-42c7-9143-b16e58f977b4	1	2016-02-04
50419-403-03	EA - Each	50419-403	6c27e5cf-2277-47be-927b-cdc9597f83fc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DROSPIRENONE	ACTIVE INGREDIENT	N295J34A25	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
LEVOMEFOLATE CALCIUM	ACTIVE INGREDIENT	A9R10K3F2F	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
DROSPIRENONE	ACTIVE MOIETY	N295J34A25	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
LEVOMEFOLIC ACID	ACTIVE MOIETY	8S95DH25XC	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
BETADEX	INACTIVE INGREDIENT	JV039JZZ3A	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SAFYRAL (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 95 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
Davimet-M	MULTIVITAMIN	PureTek Corporation	0b67e8de-d81e-0fda-e063-6394a90ac229	2023-11-30	Warnings, Adverse reactions	Exact identifier unii: A9R10K3F2F
SOOTHE Daily Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	9acbf663-15e4-4572-a267-56afa58a347b	2023-11-30	Warnings	Exact identifier unii: 15FIX9V2JP
Etonogestrel/Ethinyl Estradiol	ETONOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	fcf9da2a-bb91-4697-bfaa-c9d58855e275	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U
Aurovela 1.5/30	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	b146e49c-a0fc-4f3d-9ad6-99e8257fa139	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 423D2T571U
SPF 60 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Derma Care Research Labs, LLC	0aae69f1-66bf-a199-e063-6394a90a3d75	2023-11-21	Warnings	Exact identifier unii: 15FIX9V2JP
Aurovela 1/20	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Aurobindo Pharma Limited	6765becf-7b51-4f33-ac13-70fcd01decf7	2023-11-21	Warnings, Adverse reactions	Exact identifier unii: 423D2T571U
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a9c1b3f-656d-0d62-e063-6394a90a4731	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	581e8289-1406-45b6-9786-753800665fad	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a4cea12-7e00-d201-e063-6394a90a6691	2023-11-16	Warnings	Exact identifier unii: 15FIX9V2JP
Max Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Peter Thomas Roth Labs, LLC	0980992c-6488-2fa1-e063-6294a90a41ea	2023-11-14	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Kapa'ihi, Inc	66e5eb1b-4ef0-459d-8428-b3e2f221bc85	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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