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 8 of 109 · 2,166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	201acd8e-23c6-43fd-81dc-a814c3d8160b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b24806b1-d9da-4373-b072-6d9a262ea365	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c981ae5e-e7e8-484b-b682-fb96d501e03b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Have & Be Co., Ltd.	4a7e868d-6310-6ee4-e063-6394a90aebce	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIR	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEP	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	930bd1de-5a0e-4607-8d3c-b1ca918f890b	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	0206c676-c24d-470e-adb2-7cb3173f3727	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TAN	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	5c5aad09-9f93-4634-8db1-c67570b38b2b	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	4955fa1c-789d-4f42-af75-70223310644a	2026-05-01	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ba4ae906-48c0-8384-e053-2995a90afb91	2026-05-01	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6831832a-e52e-43ea-899f-f5d44bea5a94	2026-04-30	Warnings	Exact identifier unii: 15FIX9V2JP
Tru Skin Rituals SPF 25	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	f725cd5c-999e-2393-e053-6394a90a09dc	2026-04-30	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509cad98-0321-2a0a-e063-6294a90a6ea9	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d7206-0cc1-c997-e063-6294a90a89e0	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	GPNY CORP	211dea04-faad-8ffc-e063-6294a90a8d68	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
Anything SPF	OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE	Anything SPF LLC	508b8dcb-6600-6dad-e063-6294a90a565a	2026-04-28	Warnings	Exact identifier unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	4fe04c4b-2751-0561-e063-6394a90af768	2026-04-22	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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