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 35 of 184 · 3,666 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17a0201b-b797-4e65-838f-1ce8d408a0202026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72e2c71a-da1d-497f-a8b7-491cff951c632026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior19d1432a-96b0-4cef-b13e-895dd41b41d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a06c820-ccd8-47ce-8bbf-7e90da92b1de2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior205e195a-fd30-44f7-9294-e701f0f766d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5495ff75-0c83-4491-8af7-4aed7a779d7f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior10bc345d-a5b1-4b70-bfa6-a2d7816904bf2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30268b6e-d42a-4314-b82f-24f9e81cca2a2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior545c962f-2a59-4d94-8fef-ebdba4127f422026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior17c9226b-459c-42fe-ac50-7e26db6b49af2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbf323e10-5479-44b3-b4b9-b8ca6b0f76882026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d6a5133-b847-4ecf-8c33-1cb05aca6b912026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior275be888-2c52-43ed-846a-55525002edcd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc73576a6-dbab-4205-add5-876a060b50222026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ae761ac-df06-4913-a8bf-8ca1be32b5b72026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72c45120-6997-4250-b9b4-1cdb762efe1a2026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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