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 82 of 180 · 3,593 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b	2025-11-10	Warnings	Exact identifier unii: 3G6A5W338E
buttah Tinted Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Buttah Enterprises, LLC.	43458152-0775-dd9c-e063-6394a90a6140	2025-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Pamprin Max Menstrual Pain Relief	ACETAMINOPHEN AND ASPIRIN AND CAFFEINE	Focus Consumer Healthcare, LLC	5bd4b935-f003-7df8-e053-2a91aa0a5d79	2025-11-10	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
LUMOe SKIN1 Skin Remedy	KALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLA	Applied Bioenergetics, LLC	d4d7fd2f-66bf-407d-ad36-2462e880b9f5	2025-11-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	93e7ba56-5682-4184-9a93-3b4b972b0e72	2025-11-10	Warnings	Exact identifier unii: 3G6A5W338E unii: R16CO5Y76E
Walgreens SPF 50 Tinted Mineral Fluid	TITANIUM DIOXIDE	Walgreens	345918e3-95f8-404c-e063-6394a90a3fca	2025-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Ananassa Resina	ANANASSA RESINA	Uriel Pharmacy Inc.	52a18d0a-2c97-4e81-81ff-c836582d0a4c	2025-11-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	d690d5d1-e1fa-404f-a17e-7b97be17b44a	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	2fbdeff7-4880-49ef-bb4d-e033d18e0459	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	6a86e5fd-6736-45e0-aa7d-d268fdaed4f8	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	42a3625f-5c58-4ec5-895f-b14f74428271	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8e14fe81-cf7f-4a81-afec-e6c8466179c9	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8acb660f-94bd-4c4f-b0c1-3682cf8ed543	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	fad2bec7-c5f4-45f4-aff4-a5022033cb6a	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	39856c69-84fb-4b12-a713-8912263e42b1	2025-11-07	Warnings	Exact identifier unii: 15FIX9V2JP
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	eeb3c173-b280-76e4-e053-2995a90a0e79	2025-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	efcd52c2-4208-46a1-e053-2a95a90a857d	2025-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Teething-Colic	CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE	Newton Laboratories, Inc.	9db30229-3031-ff10-e053-2995a90aff75	2025-11-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething-Colic	CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE	Newton Laboratories, Inc.	9db4790e-28c2-2dce-e053-2a95a90ae792	2025-11-06	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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