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 77 of 109 · 2,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
toty Ilumina CC Cream 1N	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e4efe14e-7d46-78c0-e053-2995a90a2364	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMEL	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29a82ba9-c0f8-0edf-e063-6294a90a50b4	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29a8812b-70ff-e8aa-e063-6294a90a09f8	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Neutral Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE	KW ABSC, INC.	3a548deb-3670-4c5b-a139-796701801fed	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Olive Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	be4434c0-cbdd-46cb-8015-4c7859e80d4a	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Golden Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	de50e956-a014-4147-922b-63c95fa6f86b	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Neutral Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	44cbb226-83ed-401b-baf8-ca8e4740dbef	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Neutral Medium Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	615f5e39-695d-41d4-af59-e0d3b76789bb	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Warm Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE	KW ABSC, INC.	6ab3e360-8104-4439-93fb-e11bc4a77558	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Neutral Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	a297ff64-678c-4936-8384-022606a2f33c	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Neutral Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CLE CCC Cool Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	KW ABSC, INC.	2e0365f9-d3c6-4404-90ac-772a829b3ade	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abae8f-53db-b592-e063-6294a90adabb	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29aba80c-55b7-b8d9-e063-6294a90a5cc1	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abe97b-e9b3-6e27-e063-6294a90ae3ed	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29abdf3c-fb54-a5e3-e063-6394a90af450	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products, Inc.	f2e34230-7bfb-455f-8b33-6bff96fd9f0a	2024-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29868d60-b900-e0ad-e063-6294a90af87a	2024-12-18	Warnings	Exact identifier unii: 15FIX9V2JP
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	e999d752-6c00-459e-b6c3-d264c330597d	2024-12-18	Warnings	Exact identifier unii: 15FIX9V2JP
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	f22626c1-0996-41d8-a2ec-3bf7491df657	2024-12-18	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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