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 37 of 331 · 6,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel Firecracker PopALCOHOLBath & Body Works, Inc.552ff8dc-b388-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Japanese Cherry BlossomALCOHOLBath & Body Works, Inc.552fe733-25f9-30a7-e063-6294a90a44642026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pineapple MangoALCOHOLBath & Body Works, Inc.552fe733-25fc-30a7-e063-6294a90a44642026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Peach Blossom and NectarALCOHOLBath & Body Works, Inc.552feb22-c34c-0572-e063-6394a90afa8c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel ButterflyALCOHOLBath & Body Works, Inc.552ff81f-28d9-0f6e-e063-6394a90ab5832026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry KiwiALCOHOLBath & Body Works, Inc.552fe584-b74d-00ad-e063-6394a90a68e72026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Cut LilacsALCOHOLBath & Body Works, Inc.552feb22-c353-0572-e063-6394a90afa8c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Kiwi BerryALCOHOLBath & Body Works, Inc.552ff8dc-b387-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh WatermelonALCOHOLBath & Body Works, Inc.552fed13-f329-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Neapolitan Ice CreamALCOHOLBath & Body Works, Inc.552ff8dc-b38a-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.552fe6d9-3364-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Iced Lemon Pound Cake Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.552fe73b-38dc-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cozy Vanilla AlmondALCOHOLBath & Body Works, Inc.55300198-e9c1-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pina Colada SwirlALCOHOLBath & Body Works, Inc.552ffde3-ccce-2ffd-e063-6394a90a08402026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.55300198-e9bc-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sweet Tea and LemonadeALCOHOLBath & Body Works, Inc.552ffc4e-aded-ff0e-e063-6294a90abdc02026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Wildberry French ToastALCOHOLBath & Body Works, Inc.552ff81f-28da-0f6e-e063-6394a90ab5832026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cotton Candy CobwebsALCOHOLBath & Body Works, Inc.5530026f-04cf-471f-e063-6294a90a165e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Endless WeekendALCOHOLBath & Body Works, Inc.552fe73b-38e1-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vampire BloodALCOHOLBath & Body Works, Inc.55300198-e9be-4539-e063-6294a90a90f12026-06-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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