Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
- Product NDC
- 71679-307
- 11-digit product format
- 716790307
- Labeler code
- 71679
- Product ID
- 71679-307_561393c6-f876-f94a-e063-6294a90a151c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Health Pharma USA LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-07
- Substance
- CAFFEINE; ASPIRIN
- Active strength
- 65; 250 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAFFEINE | 65 mg/1 |
| ASPIRIN | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3G6A5W338E | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3590d417-272b-ae4d-e063-6394a90a5dc6 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Pain Relief | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1c083e29-8732-4ecd-ab4b-9038acbd0b9d | 2025-05-22 | Warnings | M013 |
| TYLENOL For Children Plus Adults | ACETAMINOPHEN | Kenvue Brands LLC | 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 | 2025-05-21 | Warnings | M013 |
| Children Acetaminophen | ACETAMINOPHEN | AARNA USA INC. | 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 | 2025-05-16 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 35478de8-50d0-5d0a-e063-6294a90a88ba | 2025-05-16 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 95f4b628-6d35-4f6b-91f9-b2d117f8e821 | 2025-05-16 | Warnings | M013 |
| good neighbor pharmacy childrens pain and fever | ACETAMINOPHEN | Amerisource Bergen | 268a789b-8f31-4739-9777-523249cac326 | 2025-05-13 | Warnings | M013 |
| ASPIRIN LOW DOSE | ASPIRIN LOW DOSE | AARNA USA INC. | 347edc8f-6391-b75e-e063-6394a90a1cf5 | 2025-05-06 | Warnings | M013 |
| Good Neighbor Pharmacy Infants Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2 | 2025-05-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 34157f6a-3031-4388-e063-6394a90a670f | 2025-05-01 | Warnings | M013 |
| ASPIRIN | ASPIRIN | HF Acquisition Co LLC, DBA HealthFirst | 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4 | 2025-05-01 | Warnings, Adverse reactions | M013 |
| Aspirin 81mg Enteric Coated | ASPIRIN | Advanced Rx LLC | 606067bb-b07f-444e-9465-d1e187735f3a | 2025-05-01 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 33f0e822-28af-9bb2-e063-6294a90a5175 | 2025-04-29 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 27fcca07-f845-77fe-e063-6394a90aa2f8 | 2025-04-24 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 46a6bbb9-ccd1-47a8-9e58-485f71f57063 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 061c91d5-5aa8-4556-a344-197b7e8a10b8 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 | 2025-04-24 | Warnings | M013 |
| Extra Strength No-Pain | ACETAMINOPHEN | Safrel Pharmaceuticals, LLC. | 873f01dd-0701-5fd3-e053-2a95a90a6463 | 2025-04-23 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Chain Drug Consortium | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 2025-04-16 | Warnings | M013 |
| Premsyn pms Premenstrual Pain Relief | ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 2025-04-14 | Warnings | M013 |
| BackAid Max | ACETAMINOPHEN, PAMABROM | Kobayashi Healthcare International, Inc. | fb9a5647-b7c9-4820-b148-91060e34cb83 | 2025-04-14 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 71679-307-00 | 71679030700 | 30000 TABLET, FILM COATED in 1 DRUM (71679-307-00) | 2024-03-07 | No | No | Current |
| 71679-307-03 | 71679030703 | 300 TABLET, FILM COATED in 1 BOTTLE (71679-307-03) | 2024-03-07 | No | No | Current |