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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | d1de0f93-1439-4ee3-b692-56e1a1400682 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | 3G6A5W338E 362O9ITL9D |
| LUMOe SKIN1 Skin Remedy | KALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLA | Applied Bioenergetics, LLC | d4d7fd2f-66bf-407d-ad36-2462e880b9f5 | 2025-11-10 | Warnings | ETJ7Z6XBU4 |
| Leader 8HR Arthritis Pain Relief | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f6 | 2025-11-10 | Warnings | 362O9ITL9D |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 93e7ba56-5682-4184-9a93-3b4b972b0e72 | 2025-11-10 | Warnings | 3G6A5W338E 362O9ITL9D |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | 362O9ITL9D |
| Ananassa Resina | ANANASSA RESINA | Uriel Pharmacy Inc. | 52a18d0a-2c97-4e81-81ff-c836582d0a4c | 2025-11-07 | Warnings | ETJ7Z6XBU4 |
| Pain Reliever | ACETAMINOPHEN | Shield Pharmaceuticals Corp | 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1 | 2025-11-07 | Warnings | 362O9ITL9D |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 093649a4-f968-49bd-83af-bb7e0f448ecf | 2025-11-07 | Warnings | 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | 362O9ITL9D |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | 362O9ITL9D |
| Childrens Chewables | ACETAMINOPHEN | Strategic Sourcing Services LLC | af2cbbaf-9b73-440a-bc88-a790cafccc6b | 2025-11-07 | Warnings | 362O9ITL9D |
| Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | ff0bffee-9a36-8246-e053-6294a90a86c7 | 2025-11-06 | Warnings | 362O9ITL9D |
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db30229-3031-ff10-e053-2995a90aff75 | 2025-11-06 | Warnings | ETJ7Z6XBU4 |
| Teething-Colic | CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE | Newton Laboratories, Inc. | 9db4790e-28c2-2dce-e053-2a95a90ae792 | 2025-11-06 | Warnings | ETJ7Z6XBU4 |
| Severe Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 2025-11-06 | Warnings | 362O9ITL9D |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 42321456-d7dd-3b51-e063-6394a90ac292 | 2025-11-05 | Warnings | 362O9ITL9D |
| Target Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 05e944d5-3473-4d8c-8df4-2ffc7474e9fa | 2025-11-05 | Warnings | 362O9ITL9D |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | 362O9ITL9D |
| Childrens Pain Relief | ACETAMINOPHEN | Family Dollar Services Inc | 76058eb3-2d3f-4414-87df-7167cd27d26b | 2025-11-05 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.