FDA.reportPublic FDA data

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 42 of 181 · 3,610 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
unii: R16CO5Y76E
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
unii: KHS0AZ4JVK
Caffeine 1508CAFFEINEProfessional Complementary Health Formulas970ce7be-a373-45db-b35f-f150a49d1fba2026-01-08WarningsExact identifier
unii: 3G6A5W338E
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack15a34df5-e48f-4570-9232-80e4093c46242026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
unii: KHS0AZ4JVK
unii: GSL05Y1MN6

Reported adverse events (FAERS/openFDA)#

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