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 71 of 189 · 3,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
unii: 362O9ITL9D
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCaplin Steriles Limitedb6f83919-8608-4648-9ac6-e13eadac84042025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
unii: 362O9ITL9D
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC392a846e-7325-462d-b19b-8afda44c5cb02025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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