FDA.reportPublic FDA data

NDC 70518-4309-01 - Butalbital, Acetaminophen, 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
70518-4309
Requested NDC
70518-4309-01
Package NDCs from labels
70518-4309-0, 70518-4309-1, 70518-4309-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-03
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 mgREMEDYREPACK INC.2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4309-0Butalbital, Acetaminophen, Caffeine100 in 1 BOTTLE, PLASTICTABLET1003
70518-4309-1Butalbital, Acetaminophen, Caffeine60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4309BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20250316_dc2bb7fc-1722-4865-a02c-be5e5c211505.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 50 of 188 · 3,751 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
unii: 362O9ITL9D
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
equate 8hr arthritis pain reliefACETAMINOPHENWALMART INC.36a0cac6-f5d1-4679-8bef-d52577fc0d572026-02-09WarningsExact identifier
unii: 362O9ITL9D
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
unii: 362O9ITL9D
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEGeiss, Destin & Dunn Inc.bf85fb32-66d4-4683-be9d-58ca4e9f272d2026-02-06WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENA-S Medication Solutionsfc61200e-cc40-47c4-8792-c939c9877ae22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
unii: 362O9ITL9D
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
unii: 362O9ITL9D
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
unii: 362O9ITL9D
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
unii: 362O9ITL9D
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
unii: 362O9ITL9D
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENKVK-Tech, Inc.f1063950-b302-4898-81c2-b1626c9c16ef2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
unii: 3G6A5W338E
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446e9f78-4034-5bb4-e063-6394a90ac7392026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rx446f01f0-2853-d104-e063-6394a90ae3512026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAmerican Health Packaging88e5345a-f240-473c-b329-2b0aa5f081f92026-02-04WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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