NDC 50564-507 - Butalbital, Aspirin, Caffeine and Codeine Phosphate

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: 50564-507
Package NDCs from labels: 50564-507-01, 50564-507-05
Manufacturer: Lannett Company, Inc. | Jerome Stevens Pharmaceuticals, Inc.
Effective date: 2012-05-04
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULES, USP CIII Rx ONLY	Lannett Company, Inc. \| Jerome Stevens Pharmaceuticals, Inc.	2012-05-04	HUMAN PRESCRIPTION DRUG LABEL
Codeine Phosphate - Jerome Stevens Pharmaceuticals	Jerome Stevens Pharmaceuticals	2007-10-25	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50564-507-01	Butalbital, Aspirin, Caffeine and Codeine Phosphate	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		1
50564-507-05	Butalbital, Aspirin, Caffeine and Codeine Phosphate	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50564-507	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1	2 package rows	20071101_c8b93fc1-472c-4890-8d02-2ee4f7175c22.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]	10
Aspirin	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Butalbital	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Caffeine	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Aspirin	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Butalbital	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Caffeine	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Codeine	ACTIVE MOIETY	Q830PW7520	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Colloidal Silicon Dioxide	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
D&C Red #28	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
D&C Red #33	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
D&C Yellow #10	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
D&C Yellow #10 Aluminum Lake	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
FD&C Blue #10 Aluminum Lake	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
FD&C Blue #2 Aluminum Lake	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
FD&C Red #40 Aluminum Lake	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Microcrystalline Cellulose	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Pregelatinized Starch	INACTIVE INGREDIENT		BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]	1

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 180 · 3,593 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Lift Mineral SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	40c03d65-8d09-371a-e063-6294a90a7ac6	2025-10-09	Warnings	Exact identifier unii: 15FIX9V2JP
Dr Lift Mineral SPF 30	TITANIUM DIOXIDE	Spa de Soleil	40c0e0d2-2c1d-e629-e063-6394a90a5aaf	2025-10-09	Warnings	Exact identifier unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	29817fdc-f14c-4013-a8ed-4367f3b2867c	2025-10-09	Warnings	Exact identifier unii: 15FIX9V2JP
Alert Aid	CAFFEINE	Amerisource Bergen	7f80346e-fe30-4a22-aa42-193c5fad93a2	2025-10-08	Warnings	Exact identifier unii: 3G6A5W338E
Vertra Pearl White Face Stick SPF 50	PADIMATE O, TITANIUM DIOXIDE	Eai-jr 286, Inc	b69a75e0-8724-35ae-e053-2a95a90a5f34	2025-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige	TITANIUM DIOXIDE	EAI-JR 286, Inc.	b9ea12e8-6ed9-d805-e053-2a95a90aa107	2025-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
SPF50 Sunscreen	SUNSCREEN	KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD	b3cde609-7d62-2ac7-e053-2a95a90a26b3	2025-10-07		Exact identifier unii: 15FIX9V2JP
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	f2eb9575-d527-44c7-aa5e-efabfd9a0278	2025-10-07	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Aspirin Enteric Coated	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	f1ce15a3-9824-4eb5-910a-39078165f385	2025-10-07	Warnings	Exact identifier unii: R16CO5Y76E
Parathyropar	SYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, RHUS TOX, SILICEA, PARATHORMONUM	Energique, Inc.	bd13617a-c470-4421-8f47-43a98036f40b	2025-10-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Colostat	RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA	Energique, Inc.	89c86e7b-304c-43a6-81e7-373d95c9fac1	2025-10-06	Warnings	Exact identifier unii: LMI26O6933
Mitochondria PRO	ARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,	Energique, Inc.	8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad	2025-10-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige	TITANIUM DIOXIDE	Toshiki Pigment Co., Ltd.	b9eba15f-493a-43c9-e053-2995a90a0451	2025-10-06	Warnings	Exact identifier unii: 15FIX9V2JP
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rising Pharma Holdings, Inc.	50f72713-50f5-4bab-9e96-b9fa73c9df1f	2025-10-06	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Tri-Relief Antifungal	SODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIG	Forces of Nature	6fe97b54-8aa3-4d86-9055-0629589a416b	2025-10-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
PURE SOL SPF 37 Tinted Moisturizer	ZINC OXIDE TITANIUM DIOXIDE	Brand 2022b LLC	4052c4e4-2105-80c0-e063-6294a90af41d	2025-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
Kids Mineral Sunscreen SPF50	SUNSCREEN	Hello Bello	01cc554b-9241-d891-e063-6394a90a8450	2025-10-02	Warnings	Exact identifier unii: 15FIX9V2JP
ASPIRIN 325 MG EC	ASPIRIN	Proficient Rx LP	9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77	2025-10-01	Warnings	Exact identifier unii: R16CO5Y76E
ASPIRIN	ASPIRIN	Marc Glassman, Inc.	14cb1d2d-95b8-447e-8d79-e6ec82c0e431	2025-10-01	Warnings	Exact identifier unii: R16CO5Y76E
Enteric Coated Aspirin Regular Strength	ASPIRIN	Bryant Ranch Prepack	e05140fa-9766-4f97-bffc-e36a01b9d38f	2025-10-01	Warnings	Exact identifier unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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