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 94 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02	TITANIUM DIOXIDE	3LAB, Inc.	7c6c7062-91f7-4304-98c3-f77967a2d329	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 01	TITANIUM DIOXIDE	3LAB, Inc	bd39d2fb-8326-4e19-b634-7a7308313d8a	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 03	TITANIUM DIOXIDE	3LAB, Inc	19884289-edb2-4d18-bd62-873533b94a10	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	92dc1a86-590e-4144-9d30-172645e63140	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
3LAB PERFECT BB SPF 40 Broad Spectrum 02	TITANIUM DIOXIDE	3LAB, Inc	bf4419b9-408d-469a-aa15-bbf419632f02	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin	TITANIUM DIOXIDE, ZINC OXIDE	Likewise Incorporated	28b8c519-8417-427e-8d4f-94da44a69d9f	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	c06ecc56-2044-4396-8acd-6d18af9b984c	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight	TITANIUM DIOXIDE	LOreal USA Products Inc	4692b146-1abe-48e8-b097-ea9c556962b6	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	acb887bc-7e46-4257-9fe3-a2cade6c4f38	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20	OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ddcd6ea4-e7b1-88df-e053-2a95a90a9923	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
Folixate	FOLATE, VITAMIN D3	PureTek Corporation	0bb91f61-b61b-c894-e063-6394a90ae51c	2023-12-05	Warnings, Adverse reactions	Exact identifier unii: A9R10K3F2F
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	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.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	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.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	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.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	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.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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