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 70 of 181 · 3,610 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midol Complete, Travel BASIX	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Lil' Drug Store Products, Inc	d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca	2025-12-10	Warnings	Exact identifier unii: 3G6A5W338E
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b2403-4f4a-3e77-e063-6294a90a4f0a	2025-12-10		Exact identifier unii: 15FIX9V2JP
Sheer Mineral Sunscreen Bar	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b69d5-f0e1-99cd-e063-6294a90abb6e	2025-12-10		Exact identifier unii: 15FIX9V2JP
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342c3f42-c17f-f777-e063-6394a90a8058	2025-12-10		Exact identifier unii: 15FIX9V2JP
Lip SPF	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396d3fdd-99d8-77e8-e063-6294a90aec2f	2025-12-10		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396cae82-7641-e1b2-e063-6394a90a7c07	2025-12-10		Exact identifier unii: 15FIX9V2JP
Solar Knight SPF 40 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	MASCARENAS ENTERPRISES, INC.	36c27c91-22ac-205c-e063-6294a90ab379	2025-12-10		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396ce15a-06ad-4055-e063-6294a90a27fb	2025-12-10		Exact identifier unii: 15FIX9V2JP
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Advanced Rx of Tennessee, LLC	45a18fad-ad4e-3a1b-e063-6394a90a23cf	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3G6A5W338E unii: KHS0AZ4JVK
Butalbital, Acetaminophen, and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Actavis Pharma, Inc.	ea5b9ffe-3cda-405e-8f75-3fd4a64c9a35	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3G6A5W338E unii: KHS0AZ4JVK
Fioricet	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Actavis Pharma, Inc.	c018be7d-f7b8-45e2-97b8-8e7a71740657	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3G6A5W338E unii: KHS0AZ4JVK
Low Dose Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	18b79449-5c4c-41ce-9609-80f5efa0375c	2025-12-09	Warnings	Exact identifier unii: R16CO5Y76E
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242ff053-b8c0-4f90-e063-6294a90a7bb3	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ef1f8-ad12-4f80-e063-6394a90a3e3c	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e810d366-0c32-5b1c-e053-2a95a90a622e	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242b7d0e-82d8-793c-e063-6294a90a4aa3	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	eb744367-f318-e1e2-e053-2a95a90a2cc4	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242faaed-e85a-a1d7-e063-6294a90aea92	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247d6c0e-8f88-faf0-e063-6394a90a10da	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e8241828-17b2-96c5-e053-2a95a90a12e5	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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