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 | Type |
|---|---|---|---|
| Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg CIII RX Only | REMEDYREPACK INC. | 2026-09-18 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-4601-0 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 4 | |
| 70518-4601-1 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 150 in 1 BOTTLE, PLASTIC | TABLET | 150 | 4 | |
| 70518-4601-2 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | 4 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| WALGREENS Cold Cough and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 1e903034-942e-4c6e-9f96-eb097c266580 | 2025-12-01 | Warnings | 362O9ITL9D |
| Advil Dual Action with Acetaminophen, Travel BASIX | IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 030d9bca-a934-6ef9-e063-6394a90a8277 | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Non Aspirin Extra Strength | ACETAMINOPHEN | New World Imports, Inc | da05a1a1-35b4-4787-8c56-12e369f18ff0 | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a | 2025-12-01 | Warnings | 362O9ITL9D |
| CareALL Acetaminophen Extra Strength | ACETAMINOPHEN | New World Imports, Inc | 66244cdb-2680-4fa8-890d-32aefd490038 | 2025-12-01 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Epic Pharma, LLC | 700a229f-dc2d-7086-e053-2991aa0aec91 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen and Codeine | ACETAMINOPHEN AND CODEINE | Amneal Pharmaceuticals LLC | 8bc4108b-314e-4a52-a37c-631c6b869b04 | 2025-12-01 | Boxed warning, Warnings | 362O9ITL9D |
| ENDOCET | OXYCODONE AND ACETAMINOPHEN | Par Health USA, LLC | 944d3e60-7eee-11de-a413-0002a5d5c51b | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Elite Laboratories, Inc. | 6286e128-1288-4dc0-b14b-f04a0e2a22f9 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY, INC | bbb1b395-48d9-4859-ad52-6650961089d9 | 2025-12-01 | Warnings | 362O9ITL9D |
| Family Wellness Childrens Pain Reliever 574 | ACETAMINOPHEN | Family Dollar Services, Inc. | 902c1136-04d2-41f0-81c6-412663cdf378 | 2025-12-01 | Warnings | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Alvogen, Inc. | 900ec197-720e-5428-b526-055b7756aa4a | 2025-11-30 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Severe Sinus Pain and Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fbc541ac-9465-4296-bb1e-811b9d811f40 | 2025-11-26 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | WALGREENS CO. | bfc58cd5-9815-43af-895d-ec6cbd10937e | 2025-11-26 | Warnings | 362O9ITL9D |
| WalgreenChildrens Pain Fever | ACETAMINOPHEN | WALGREENS CO. | 2f757cde-2604-4ca4-b54e-e444f3757cdd | 2025-11-26 | Warnings | 362O9ITL9D |
| Walgreen Childrens Pain plus Fever | ACETAMINOPHEN | WALGREENS CO. | 29ca2855-3c07-435d-a8e1-2997fcedd088 | 2025-11-26 | Warnings | 362O9ITL9D |
| Walgreens Childrens Cold plus Cough plus Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 8714d4e6-3a3b-48c8-8ac1-51b933a2ceac | 2025-11-26 | Warnings | 362O9ITL9D |
| Walgreen Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 2025-11-26 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Asclemed USA, Inc. | cce09e09-158f-4927-8a3e-4ec9334f0b7a | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 238154 3G6A5W338E KHS0AZ4JVK 362O9ITL9D |
| Pain Reliever, 24/7 Life by 7-Eleven | ACETAMINOPHEN TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44828b89-2563-b233-e063-6294a90ab124 | 2025-11-26 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.