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 36 of 331 · 6,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Moisturizing Hand Sanitizer Peach BelliniALCOHOLBath & Body Works, Inc.552fd963-5f09-0acc-e063-6294a90a2c142026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Fresh RainfallALCOHOLBath & Body Works, Inc.552faf37-a7ff-df22-e063-6394a90a47cb2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Sparkling WatermelonALCOHOLBath & Body Works, Inc.552fe62e-5e14-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Warm Vanilla SugarALCOHOLBath & Body Works, Inc.552fbc11-1720-fe10-e063-6294a90ac2362026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Champagne ToastALCOHOLBath & Body Works, Inc.552fc4da-f24c-e88a-e063-6394a90ae2ab2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Eucalyptus MintALCOHOLBath & Body Works, Inc.552fc8da-e38a-0dc5-e063-6294a90a9c0c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mango Papaya ParadiseALCOHOLBath & Body Works, Inc.552fe73b-38de-0c49-e063-6394a90a64742026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Strawberry Peach SunsetALCOHOLBath & Body Works, Inc.552fe62e-5e13-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.552fed13-f320-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Peach BlossomALCOHOLBath & Body Works, Inc.552feb22-c355-0572-e063-6394a90afa8c2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.552fccdd-93c4-efff-e063-6294a90a54ba2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberry TangerineALCOHOLBath & Body Works, Inc.552fe6d9-335d-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Marine Waves and CitrusALCOHOLBath & Body Works, Inc.552fe62e-5e18-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Watermelon LemonadeALCOHOLBath & Body Works, Inc.552fe6d9-335f-0842-e063-6394a90a98452026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Turquoise WatersALCOHOLBath & Body Works, Inc.552fe62e-5e1e-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus RainALCOHOLBath & Body Works, Inc.552ff8dc-b386-0c47-e063-6394a90a47c32026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Waikiki Beach CoconutALCOHOLBath & Body Works, Inc.552fe62e-5e1d-1fed-e063-6294a90a489e2026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Pineapple SunriseALCOHOLBath & Body Works, Inc.552fed13-f326-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Coconut Pina ColadaALCOHOLBath & Body Works, Inc.552fe733-25f7-30a7-e063-6294a90a44642026-06-26WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh RainfallALCOHOLBath & Body Works, Inc.552fed13-f323-27bc-e063-6294a90ae1312026-06-26WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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