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 |
|---|---|---|---|---|---|---|
| Bambusa Viscum Stannum | BAMBUSA VISCUM STANNUM | Uriel Pharmacy Inc. | 7b2a95d0-6f51-4a6b-b05f-fe7d13d83b89 | 2025-11-14 | Warnings | ETJ7Z6XBU4 |
| Earthmed Uplift Chewable Orange | CAFFEINE | Earthmed LLC | 43958b2a-c2cd-bbf9-e063-6294a90a66d9 | 2025-11-14 | Warnings | 3G6A5W338E |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | 362O9ITL9D |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | 3G6A5W338E 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | 362O9ITL9D |
| Robitussin Maximum Strength Severe Cough Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 6a6f5da8-6433-4284-8df7-2d5b099b74dc | 2025-11-13 | Warnings | 362O9ITL9D |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | 7a78f24b-7c23-4318-99dc-90c05db185b1 | 2025-11-13 | Warnings | 362O9ITL9D |
| BELLA HP | ATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA. | Natural Creations, Inc. | 8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b1 | 2025-11-13 | Warnings | ETJ7Z6XBU4 |
| BONE HP | SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT. | Natural Creations, Inc. | 93d2b385-9ce3-4d16-b428-1638e9a55f92 | 2025-11-13 | Warnings | ETJ7Z6XBU4 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b6da1659-8c79-4cce-a817-907a7f061a2d | 2025-11-13 | Warnings | 362O9ITL9D |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 7f78028a-484b-48b3-a37a-1e0b055bbefc | 2025-11-13 | Warnings | 362O9ITL9D |
| OneSsip Acetaminophen | ACETAMINOPHEN | MEDWISE LIFESCIENCES INC. | 3f88de0f-6cf6-3580-e063-6294a90abcb4 | 2025-11-12 | Warnings | 362O9ITL9D |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | AvKARE | f5bbad36-6a0e-3518-3f12-138ae9f63980 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 3G6A5W338E KHS0AZ4JVK 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | 362O9ITL9D |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | 362O9ITL9D |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | 362O9ITL9D |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | 362O9ITL9D |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | 3G6A5W338E 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.