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 39 of 331 · 6,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
serendipity3 HAND SANITIZER Lavender Milk SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2bbfe7fa-5cea-4a41-be24-d7d27cce26102026-06-24WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER ORANGE BLOSSOM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO89c02ce5-267f-46f0-b4ef-0045a638670a2026-06-24WarningsExact identifier
unii: 3K9958V90M
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
unii: 362O9ITL9D
AURA LANE HAND SANITIZER WHITE JASMINE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOf8abc0f4-0919-480a-8462-fbbbcb2fd6f82026-06-24WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER STRAWBERRY FIZZ SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO27b5003e-cd8e-4195-8a71-6ae2705138902026-06-24WarningsExact identifier
unii: 3K9958V90M
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackef2c1fe2-75dd-43cf-871d-540c5e36d3632026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSagent Pharmaceuticals621282f6-75b3-401b-8e1a-c5153a0c9ecd2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackfcb09a57-76d8-413c-801b-8d8ea0c3f1db2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizers 2pk Apple and MarshmallowALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6b242-6f50-0e3e-e063-6294a90a52692026-06-23WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Silicone Holiday Gift Set 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6ecb7-5cd5-fc13-e063-6294a90a038c2026-06-23WarningsExact identifier
unii: 3K9958V90M
Blood Collection SystemCP2D/AS-3 TRIPLE WITH SAMPLING SYSTEMGVS TM INC54e8cfd2-f91b-8381-e063-6394a90a3f772026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54e9a497-7a94-44c9-e063-6294a90a84da2026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
unii: IY9XDZ35W2
Family Beauty Hydrating Hand Sanitizer, Aloe ScentedALCOHOLFamily Dollar Stores, LLC394c35ad-90b1-476c-84b9-2dbf973444532026-06-23WarningsExact identifier
unii: 3K9958V90M
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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