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 2 of 184 · 3,666 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreen Company	36503181-0fda-4127-b3f0-bdb1b56bb0ed	2026-08-24	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Stay Awake	CAFFEINE	United Natural Foods, Inc. dba UNFI	15e4d040-ed21-46e7-98c6-56267f388f57	2026-08-21	Warnings	Exact identifier unii: 3G6A5W338E
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Publix Super Markets Inc	a876daa7-ade3-497d-87bb-46d6e4dc185a	2026-08-21	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Psorinum Complex	PHOSPHORUS, SILICEA, SULPHUR, ALOE	BioActive Nutritional, Inc.	d4746927-e6d4-463d-a084-56ffc48d1e67	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Boneforce HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE	BioActive Nutritional, Inc.	d96ca52b-781d-431c-ad2a-a54fd57eb106	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
equate aspirin	ASPIRIN	Wal-Mart Stores Inc	ea3f8eed-7b70-4156-9586-125d27bf29a8	2026-08-19	Warnings	Exact identifier unii: R16CO5Y76E
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	5c96d033-bf7c-47de-aa0d-5998b3bf4a63	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: GSL05Y1MN6
aspirin chewable, low dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	6a6ac7fe-91a4-4b55-979a-b53b51505d8b	2026-08-19	Warnings	Exact identifier unii: R16CO5Y76E
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway, Inc.	5e77dca4-2ff8-4a8c-94bd-f224b680ca23	2026-08-19	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg	ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE	Major Pharmaceuticals	a6e652e1-b2e4-47ba-bed2-c5e902f8b8f1	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: R16CO5Y76E
Headache Formula Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	ARMY AND AIR FORCE EXCHANGE SERVICE	ee8d0961-7572-471f-8c96-b4c0bd354de2	2026-08-18	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cerebellum Thalamus A Aurm	CEREBELLUM THALAMUS A AURUM	Uriel Pharmacy Inc.	e1c395b8-9221-401f-8980-c91ff8843458	2026-08-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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