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 87 of 180 · 3,593 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caffeine	CAFFEINE	CVS Pharmacy, Inc.	6de63f21-c3b4-0c2f-e053-2991aa0a7886	2025-10-16	Warnings	Exact identifier unii: 3G6A5W338E
DD Cream	DD CREAM	DERMAdoctor, Inc.	08c9a0cf-ee78-483b-e054-00144ff88e88	2025-10-16	Warnings	Exact identifier unii: 15FIX9V2JP
Orphenadrine Citrate, Aspirin and Caffeine	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Atland Pharmaceuticals, LLC	61ca2af1-081c-411c-90ce-ec6d9e3157b2	2025-10-16	Warnings, Adverse reactions	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Butalbital And Acetaminophen	BUTALBITAL AND ACETAMINOPHEN	Larken Laboratories, Inc.	326c83fc-afed-45ad-9c87-f47968fa1d2a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: KHS0AZ4JVK
Ciele Filter and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Ciele	0309b0ef-baca-b41d-e063-6294a90a49d7	2025-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50	SUNSCREEN	Epicuren Discovery	41367f05-59d8-6736-e063-6394a90a5f17	2025-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	41386de5-5857-efab-e063-6294a90afd9c	2025-10-15	Warnings	Exact identifier unii: R16CO5Y76E
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	4138d4c0-baa5-1f20-e063-6394a90a788f	2025-10-15	Warnings	Exact identifier unii: R16CO5Y76E
TEXACLEAR PAIN RELIEVER	CAFFEINE, CHOLINE SALICYLATE	GM Pharmaceuticals, INC	065bd10c-3bcf-486f-a49c-40544127007f	2025-10-15	Warnings	Exact identifier unii: 3G6A5W338E
DENTI BUONGIORNO PEACH MINT WHITENING TOOTH	HYDROGEN PEROXIDE, SILICA	ATOSAFE CO., Ltd	41196c2f-8e2e-a54d-e063-6294a90ad8a7	2025-10-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTH	HYDROGEN PEROXIDE, SILICA	DONG IL PHARMS CO.,LTD	41198822-7c8f-ceb2-e063-6394a90a4373	2025-10-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTH	SILICA, SODIUM MONOFLUOROPHOSPHATE	DONG IL PHARMS CO.,LTD	41197bb6-f6f4-c86d-e063-6294a90ad476	2025-10-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE , ZINC OXIDE	Skinlycious Pte Ltd	e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea	2025-10-13	Warnings	Exact identifier unii: 15FIX9V2JP
DENTI BUONGIORNO ORIGINAL TOOTH	SILICA, SODIUM MONOFLUOROPHOSPHATE	ATOSAFE CO., Ltd	4114ab09-1115-6b0b-e063-6394a90ab442	2025-10-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTH	SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE	ATOSAFE CO., Ltd	41155922-d7ac-0a7a-e063-6294a90afe48	2025-10-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTH	SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE	DONG IL PHARMS CO.,LTD	41157552-2473-176b-e063-6294a90a9ad0	2025-10-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTH	SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE	ATOSAFE CO., Ltd	4115d122-3090-d3e5-e063-6294a90aafb6	2025-10-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTH	SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE	DONG IL PHARMS CO.,LTD	4115b653-63ff-703f-e063-6294a90a652a	2025-10-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	b6c316c3-661b-6428-e053-2a95a90a1a6b	2025-10-10	Warnings	Exact identifier unii: 15FIX9V2JP
Silicea Belladonna	SILICEA BELLADONNA	Uriel Pharmacy Inc.	a142eb87-c5fb-4138-bc98-e7f1391fe221	2025-10-10	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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