NDC 68071-3249-06 - 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
68071-3249
Requested NDC
68071-3249-06
Package NDCs from labels
68071-3249-2, 68071-3249-3, 68071-3249-6, 68071-3249-0, 68071-3249-06
Manufacturer
NuCare Pharmaceuticals, Inc. | NuCre Pharmaceuticals, Inc.
Effective date
2025-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mgNuCare Pharmaceuticals, Inc. | NuCre Pharmaceuticals, Inc.2025-01-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-3249-02023-04-17Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-22023-04-17Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-32023-04-17Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-62023-04-17Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-02023-01-30Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-22023-01-30Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-32023-01-30Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-62023-01-30Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-02021-02-11Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-22021-02-11Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-32021-02-11Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-62021-02-11Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-02021-01-29Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-22021-01-29Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-32021-01-29Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
68071-3249-62021-01-29Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3249-0Butalbital, Acetaminophen, and Caffeine10 in 1 BOTTLETABLET108
68071-3249-2Butalbital, Acetaminophen, and Caffeine20 in 1 BOTTLETABLET208
68071-3249-3Butalbital, Acetaminophen, and Caffeine30 in 1 BOTTLETABLET308
68071-3249-6Butalbital, Acetaminophen, and Caffeine60 in 1 BOTTLETABLET608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3249BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [NUCARE PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20250104_4ecb7bdc-4a43-7444-e054-00144ff88e88.zip

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 5 of 188 · 3,757 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 362O9ITL9D
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Stay AwakeCAFFEINEUnited Natural Foods, Inc. dba UNFI15e4d040-ed21-46e7-98c6-56267f388f572026-08-21WarningsExact identifier
unii: 3G6A5W338E
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
unii: 362O9ITL9D
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
unii: 362O9ITL9D
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
unii: 362O9ITL9D
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: 362O9ITL9D
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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