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 19 of 331 · 6,618 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mistify Hand Sanitizer Soft Serve And Cherry CrushALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987ed0c-2560-f787-e063-6394a90af7bd2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Coconut And Whipped CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5988393d-1554-5588-e063-6394a90a470f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Green Apple And WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598ec764-bad1-d14b-e063-6394a90a23052026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Blue Blueberry And Waffle SyrupALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598f14fc-c34c-0b4e-e063-6394a90acf0c2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Lavender Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0a6abf-fbab-3db5-e063-6294a90a6a302026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Watermelon Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ac249-7b91-a83f-e063-6294a90a93742026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA SUGAR COOKIES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0b1e6c-850c-05e0-e063-6294a90afa462026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY SUGAR RUSH HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ba647-ee25-952a-e063-6294a90ad4712026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify twin cherry hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a148ff2-42bd-7288-e063-6394a90aae642026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer StrawberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a170880-4867-9aac-e063-6394a90a3e4f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify strawberry and cream hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a2b3f7b-5981-ed93-e063-6294a90a7b192026-08-01WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Green Certified FoamALCOHOLGOJO Industries, LLC57d91ee6-a166-dc13-e063-6294a90a2f5e2026-07-31WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer GelALCOHOLGOJO Industries, LLC57ecffc4-2c30-84ad-e063-6394a90a68e72026-07-31WarningsExact identifier
unii: 3K9958V90M
Zoono Ultra Hand SanitizerALCOHOLZoono Holdings USA, LLC3dbb255c-1256-66a7-e054-00144ff8d46c2026-07-31WarningsExact identifier
unii: 3K9958V90M
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
unii: 362O9ITL9D
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
unii: 362O9ITL9D
Dehydrated AlcoholALCOHOLAvenacy, LLC90e92d21-9821-4132-b17d-d98d523f12e82026-07-31Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
unii: 362O9ITL9D
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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