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 88 of 109 · 2,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee2842c3-65e0-3904-e053-2a95a90aabff	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Firecracker	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee026a1c-885b-256f-e053-2a95a90af564	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ec96dee8-85e8-3147-e053-2995a90aaf53	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess	TITANIUM DIOXIDE	COOLA, LLC	eeb406c6-a543-379a-e053-2995a90a4998	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose	TITANIUM DIOXIDE	COOLA, LLC	ee01642f-478e-b307-e053-2a95a90a7d81	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Untinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ecabcc89-fb09-41a9-e053-2995a90a8b31	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Tinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee018c21-dca7-28aa-e053-2a95a90a3bdb	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Golden Daze	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eeb70034-0f8d-a46d-e053-2a95a90a8130	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Diamond Dust	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eec83ecb-d0ab-7857-e053-2995a90a40ed	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs LLC	18e1edd9-e39b-c91f-e063-6394a90a32a0	2024-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs, LLC	18e4c50d-eb91-c269-e063-6394a90a7999	2024-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	18aa2604-c8f0-ca04-e063-6294a90a1c25	2024-05-17	Warnings	Exact identifier unii: 15FIX9V2JP
Jack Black	TITANIUM DIOXIDE, ZINC OXIDE	Jack Black L.L.C	181d5bf3-ce91-cb2c-e063-6294a90a51c4	2024-05-10	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Fair Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	181e3f34-c5b2-0976-e063-6394a90a9a78	2024-05-10	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	180b2939-5ae4-88fb-e063-6394a90aad93	2024-05-09	Warnings	Exact identifier unii: 15FIX9V2JP
Prenatol-M	MULTIVITAMIN	PureTek Corporation	17559a44-94b7-9ca0-e063-6294a90a2123	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: A9R10K3F2F
Natural Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sarati International, Inc.	16ef922d-78d1-1e70-e063-6394a90a3bbf	2024-04-25	Warnings	Exact identifier unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Alabaster	TITANIUM DIOXIDE	Chantecaille Beaute Inc	e1c562b8-76c0-4c6e-9276-900784c8639e	2024-04-24	Warnings	Exact identifier unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Wheat	TITANIUM DIOXIDE	Chantecaille Beaute Inc	89f19f7a-60e3-4080-a49a-a4eb3e6c27de	2024-04-24	Warnings	Exact identifier unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Aura	TITANIUM DIOXIDE	Chantecaille Beaute Inc	de441a6c-55e3-4b11-afb3-d7db3c6971f0	2024-04-24	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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