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 52 of 329 · 6,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLCe072e4ab-669d-40ee-b301-0bc15b67792f2026-05-21WarningsExact identifier
unii: 362O9ITL9D
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HBRAMERISOURCE BERGEN45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e2026-05-21WarningsExact identifier
unii: 362O9ITL9D
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5251a3e8-f499-7775-e063-6294a90a44bf2026-05-21WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.51ae09af-1ce4-2831-e063-6294a90ab6a52026-05-21WarningsExact identifier
unii: 3K9958V90M
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
unii: 362O9ITL9D
Scentfull Midnight Air Hand SanitizerALCOHOLScent Theory Products LLC52561c01-574a-81e8-e063-6294a90a5f822026-05-21WarningsExact identifier
unii: 3K9958V90M
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
unii: 362O9ITL9D
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
unii: 362O9ITL9D
DEHYDRATED ALCOHOLALCOHOLAccord Healthcare, Inc.07fa92f7-d752-42e3-a572-b552461c43892026-05-21Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.441d2629-3fff-0bf1-e063-6394a90aa9b62026-05-21WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d1bde-d677-fab7-e063-6394a90aaad42026-05-21WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d3a39-cc55-3c7c-e063-6394a90ad7a72026-05-21WarningsExact identifier
unii: 362O9ITL9D
Arthritis PainACETAMINOPHENGrocery Outlet, Inc.441d0aa0-9a65-98e9-e063-6294a90a5eb22026-05-21WarningsExact identifier
unii: 362O9ITL9D
THE WORLD OF Strawberry ShortcakeALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.52581a49-181f-7db4-e063-6394a90a46f42026-05-21WarningsExact identifier
unii: 3K9958V90M
FIGS evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLCosmetic Enterprises Ltd525c16f9-e9e0-24ab-e063-6394a90a669d2026-05-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Lip Gloss StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a9ac5-3f80-ca8d-e063-6394a90ab5e72026-05-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Lip Gloss WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b4aa4-e673-edb4-e063-6294a90a90542026-05-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Lip Gloss Care BearALCOHOLShenzhen Lantern Scicence Co.,Ltd.523b9b5a-30a0-1555-e063-6294a90abf912026-05-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Lip Gloss Polly PocketALCOHOLShenzhen Lantern Scicence Co.,Ltd.523bf360-16c7-e176-e063-6294a90a933f2026-05-20WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.523cd61a-c2ee-2c70-e063-6294a90a6c772026-05-20WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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