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 41 of 331 · 6,601 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8ad0df84-e3f6-4c1d-b791-c8467eb984aa2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
dg health 8 hr arthritis pain reliefACETAMINOPHENDolgencorp Incfc7838a7-fc6d-41b7-b8e4-97bee2bfa6d42026-06-17WarningsExact identifier
unii: 362O9ITL9D
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
unii: 3K9958V90M
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
unii: 3K9958V90M
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
unii: 362O9ITL9D
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
unii: 362O9ITL9D
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
unii: 3K9958V90M
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
unii: 362O9ITL9D
Equate Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.4b111580-cd20-43ec-9ff4-4b9f74f7d2e82026-06-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
unii: 362O9ITL9D
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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