FDA.reportPublic FDA data

NDC 70518-4601-01 - 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
70518-4601
Requested NDC
70518-4601-01
Package NDCs from labels
70518-4601-0, 70518-4601-1, 70518-4601-2, 70518-4601-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-18
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 50 mg/325 mg/40 mg CIII RX OnlyREMEDYREPACK INC.2026-09-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4601-0BUTALBITAL, ACETAMINOPHEN AND CAFFEINE90 in 1 BOTTLE, PLASTICTABLET904
70518-4601-1BUTALBITAL, ACETAMINOPHEN AND CAFFEINE150 in 1 BOTTLE, PLASTICTABLET1504
70518-4601-2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE120 in 1 BOTTLE, PLASTICTABLET1204

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 61 of 189 · 3,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC57e1fe79-eb60-4f4f-bb38-6df0270d408f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: 362O9ITL9D
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
unii: 3G6A5W338E
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
unii: 362O9ITL9D
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
unii: 362O9ITL9D
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
unii: 362O9ITL9D
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
unii: 362O9ITL9D
Menstrual Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFamily Dollar Services Ince7e49ebb-4df4-420e-9b9d-74ee707544872026-01-07WarningsExact identifier
unii: 362O9ITL9D
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
Stay AwakeCAFFEINEARMY AND AIR FORCE EXCHANGE SERVICE44d60bfb-4320-4f5b-8a22-9a984805ddaf2026-01-06WarningsExact identifier
unii: 3G6A5W338E
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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