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 40 of 109 · 2,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daily Defense Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JADEIA LIMITED INC	35cf708c-244e-63a8-e063-6394a90a3b96	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus Primer	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e81e8e-0ba7-93e6-e063-6294a90a4e62	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus Primer	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e84147-5dcd-517a-e063-6394a90a54ee	2025-12-15		Exact identifier unii: 15FIX9V2JP
Artificial Tears	GLYCERIN	NuCare Pharmaceuticals,Inc.	97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	2025-12-15	Warnings	Exact identifier unii: 3NXW29V3WO
Tinted Mineral Sunscreen Plus Primer Matte	TITANIUM DIOXIDE, ZINC OXIDE	Simply Bare Waxing & Skin Care LLC	36d8e8ba-a3dd-257d-e063-6294a90a30d6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e9e8d7-3fcf-1e94-e063-6394a90a8dc6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Sun Protection	TITANIUM DIOXIDE, ZINC OXIDE	HELLO BEAUTIFUL SKIN STUDIO	36d45b48-e08d-ef40-e063-6394a90a635c	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Sun Protection	TITANIUM DIOXIDE, ZINC OXIDE	HELLO BEAUTIFUL SKIN STUDIO	36d439fb-b9cf-2774-e063-6294a90ae885	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer Matte	TITANIUM DIOXIDE, ZINC OXIDE	Simply Bare Waxing & Skin Care LLC	36d9d83b-7da7-a006-e063-6394a90a9d84	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Sun Protection	TITANIUM DIOXIDE, ZINC OXIDE	HELLO BEAUTIFUL SKIN & ACNE	36d3ebc0-1de6-1998-e063-6294a90a02e6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Sun Safe Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	REVIVE IN SOLANO	36c4f0c9-5789-ca58-e063-6394a90a2323	2025-12-15		Exact identifier unii: 15FIX9V2JP
Titanium Dioxide, Zinc Oxide	ON THE GO SUNSCREEN STICK	REVIVE IN SOLANO	36c57e6f-c747-9926-e063-6294a90a5721	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Shade Matte Tinted	TITANIUM DIOXIDE, ZINC OXIDE	BLISS BEAUTY LLC	3739bdb8-2152-b2ba-e063-6294a90acd94	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Shade Matte Tinted	TITANIUM DIOXIDE, ZINC OXIDE	BLISS BEAUTY LLC	37396a51-225d-7669-e063-6294a90af6d3	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Lip Shade Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BLISS BEAUTY LLC	373a7c01-ba9f-4b00-e063-6294a90ae1a2	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Shade Matte Tinted	TITANIUM DIOXIDE, ZINC OXIDE	BLISS BEAUTY LLC	373b7ab9-c692-fc1b-e063-6294a90aa803	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36af24e2-015a-a9a7-e063-6294a90a2fce	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36add3a3-f1ff-3986-e063-6394a90ab7fe	2025-12-15		Exact identifier unii: 15FIX9V2JP
COOLA BARE REPUBLIC MINERAL SPORT SPF50	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	bbf15e58-c160-d599-e053-2a95a90a0696	2025-12-14	Warnings	Exact identifier unii: 15FIX9V2JP
Lip Protecting	TITANIUM DIOXIDE, ZINC OXIDE	JOHANNA'S SKIN CARE	3544b8f2-2651-4c01-e063-6394a90ae53d	2025-12-12		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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