FDA.reportPublic FDA data

NDC 46672-633-01 - Butalbital, Acetaminophen and Caffeine

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
46672-633
Requested NDC
46672-633-01
Package NDCs from labels
46672-633-28, 46672-633-16, 46672-633-01, 46672-633-04
Manufacturer
Mikart, LLC
Effective date
2020-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Butalbital, Acetaminophen and Caffeine - Mikart, LLCMikart, LLC2020-09-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP [MIKART, INC.]3

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 16 of 331 · 6,618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
unii: 3K9958V90M
NalocetOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLCf5f7dfca-a5c7-4445-8a5e-9ec62f33f5be2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Uline Hand SanitizerALCOHOLUlinea7aa3bde-d36e-f9d4-e053-2a95a90a6e6a2026-08-06WarningsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing Wipes LavenderALCOHOLMagicare Tech Corp9b66b3bd-1e08-485e-b961-b67a2fcc47512026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENPar Healthe619b656-4123-4878-b601-b0edad3c428b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: KHS0AZ4JVK
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
unii: 362O9ITL9D
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.ba91112c-5091-4972-84c9-5447eb0b504c2026-08-06WarningsExact identifier
unii: 3K9958V90M
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEARMY AND AIR FORCE EXCHANGE SERVICE8282cb5a-6c38-4500-93bb-461e4d65df1c2026-08-05WarningsExact identifier
unii: 362O9ITL9D
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
unii: 362O9ITL9D
Hand Sanitizer GelETHYL ALCOHOLApollo Health and Beauty Care5245e2a0-f871-ded0-e063-6394a90a86072026-08-05WarningsExact identifier
unii: 3K9958V90M
Vitamin E and AloeETHYL ALCOHOLApollo Health and Beauty Care52460290-a376-24b3-e063-6394a90a63482026-08-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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