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
LabelManufacturerEffective dateType
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULES, USP CIII Rx ONLYLannett Company, Inc. | Jerome Stevens Pharmaceuticals, Inc.2012-05-04HUMAN PRESCRIPTION DRUG LABEL
Codeine Phosphate - Jerome Stevens PharmaceuticalsJerome Stevens Pharmaceuticals2007-10-25HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50564-507-01Butalbital, Aspirin, Caffeine and Codeine Phosphate100 in 1 BOTTLE, PLASTICCAPSULE1001
50564-507-05Butalbital, Aspirin, Caffeine and Codeine Phosphate500 in 1 BOTTLE, PLASTICCAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50564-507BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]12 package rows20071101_c8b93fc1-472c-4890-8d02-2ee4f7175c22.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [LANNETT COMPANY, INC.]10
AspirinACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
ButalbitalACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
CaffeineACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
AspirinACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
ButalbitalACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
CaffeineACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
CodeineACTIVE MOIETYQ830PW7520BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Colloidal Silicon DioxideINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
D&C Red #28INACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
D&C Red #33INACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
D&C Yellow #10INACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
D&C Yellow #10 Aluminum LakeINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
FD&C Blue #10 Aluminum LakeINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
FD&C Blue #2 Aluminum LakeINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
FD&C Red #40 Aluminum LakeINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
GelatinINACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Microcrystalline CelluloseINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Pregelatinized StarchINACTIVE INGREDIENTBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
TalcINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [JEROME STEVENS PHARMACEUTICALS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, 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 67 of 181 · 3,610 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
unii: 15FIX9V2JP
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
unii: 15FIX9V2JP
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350ad191-e51c-083d-e063-6394a90aa6462025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350b2246-6e00-38fc-e063-6294a90ae3822025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Facial Protection SPF40TITANIUM DIOXIDE, ZINC OXIDEFRESH FACED SKIN CARE LLC35d08e2a-b118-8634-e063-6294a90a918d2025-12-11Exact identifier
unii: 15FIX9V2JP
Anti-Aging Sun Protection NTTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351a20df-bd8a-8ea6-e063-6294a90abaaf2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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