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 |
|---|---|---|---|---|---|---|
| TEXACLEAR PAIN RELIEVER | CAFFEINE, CHOLINE SALICYLATE | GM Pharmaceuticals, INC | 065bd10c-3bcf-486f-a49c-40544127007f | 2025-10-15 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | ASCLEMED USA INC. | db8e6702-88ac-4db2-9dd8-7d0ed997c2b5 | 2025-10-14 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreen Company | fa33f6ef-522b-4630-9716-92371d9cd24a | 2025-10-14 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Rite Aid Corporation | a8bb4f45-7a1a-4bf7-92ca-3afd508032f3 | 2025-10-09 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Health Pharma USA LLC | b15a7dcb-f143-4aea-8850-d0aacbf709b6 | 2025-10-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PD-Rx Pharmaceuticals, Inc. | 3f96aeb1-a533-4d36-9a1f-62fc094b6754 | 2025-10-08 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreens | f2eb9575-d527-44c7-aa5e-efabfd9a0278 | 2025-10-07 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bbc704e5-79f6-4c72-846b-cc30c5c43cb4 | 2025-10-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | f1ce15a3-9824-4eb5-910a-39078165f385 | 2025-10-07 | Warnings | M013 |
| BupropiDex | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 90cc9bcd-7891-4324-a1f4-f6df7a0457e0 | 2025-10-06 | Warnings | M013 |
| Dextabs | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 71b567df-844a-4563-b85a-f4592233f37d | 2025-10-06 | Warnings | M013 |
| Acetaminophen, Aspirin and Caffeine | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rising Pharma Holdings, Inc. | 50f72713-50f5-4bab-9e96-b9fa73c9df1f | 2025-10-06 | Warnings | M013 |
| OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL | ACETAMINOPHEN 160 MG / 5 ML | MEDWISE LIFESCIENCES INC. | 40507559-aee4-a603-e063-6394a90afc4f | 2025-10-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 004c39cd-b4f4-1cae-e063-6394a90a0697 | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | 43573e35-6776-446e-aa28-75c8edc5b98d | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | f8e5fab4-1212-4c60-a160-9b782f76a198 | 2025-10-03 | Warnings | M013 |
| CVS Acetaminophen | ACETAMINOPHEN | CVS Pharmacy | 3d71a0aa-5e03-0bdc-e063-6294a90a6634 | 2025-10-02 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | cc865351-34e8-4e8e-b8bf-23336c45bc61 | 2025-10-02 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Bryant Ranch Prepack | 8e40f8f1-03c5-444b-8b5e-4532c3146e47 | 2025-10-02 | Warnings | M013 |
| ASPIRIN 325 MG EC | ASPIRIN | Proficient Rx LP | 9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77 | 2025-10-01 | 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 |