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 |
|---|---|---|---|---|---|---|
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Unifirst First Aid Corporation | b56b4110-fb8f-e5a0-e053-2995a90a0ad3 | 2025-09-08 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | 64c642b7-ef83-44b7-a014-6fa248dff3ba | 2025-09-08 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE | BJWC (Berkley & Jensen / BJ's) | 2f473f1f-7cf3-2af5-e063-6394a90aaa17 | 2025-09-01 | Warnings | M013 |
| foster and thrive rapid release pain relief | ACETAMINOPHEN | Strategic Sourcing Services LLC | d2130173-b107-4ae6-a1f7-6db467da3820 | 2025-08-30 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Precision Dose, Inc. | e1d4f562-433c-4344-9b77-1a7c731d1be5 | 2025-08-29 | Warnings | M013 |
| Aspirin Enteric Coated Low Dose | ASPIRIN | Walgreen Company | b11a4c4e-374c-403e-a757-5e9700f9f03b | 2025-08-27 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Safeway | 0e0a73f9-8c18-41fd-812e-8be20287e77a | 2025-08-26 | Warnings | M013 |
| Aspirin Low Dose Safety Coated | ASPIRIN | BJWC (Berkley & Jensen / BJ's) | 577035a5-88ab-431c-8598-7a19dd633fe9 | 2025-08-26 | Warnings | M013 |
| Topcare Pain Relief | ACETAMINOPHEN | Sixarp, LLC | 2e20be17-2b6c-1a07-e063-6394a90acdd3 | 2025-08-25 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | BJWC (Berkley & Jensen / BJ's) | 2f32b096-d29a-c7c7-e063-6294a90a2bbe | 2025-08-22 | Warnings | M013 |
| Medique Medi Seltzer | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Unifirst First Aid Corporation | 528da9d9-2a52-4c16-b7b2-61b3eee1abea | 2025-08-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Publix Super Markets Inc | 6b691dc1-09e4-46d3-b199-8917e42848a6 | 2025-08-19 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | P & L Development, LLC | 59eb14a5-40b0-4331-beb5-7166e6cdf411 | 2025-08-18 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | caf5daea-409e-5dd2-e053-2995a90acb12 | 2025-08-18 | Warnings | M013 |
| Dr Simi Pain Relief 100 | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c42e48d-cdb2-eb74-e063-6394a90a2940 | 2025-08-13 | Warnings | M013 |
| Dr Simi Pain Relief | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c477d33-a8c2-d39f-e063-6294a90ac5f0 | 2025-08-13 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | CHAIN DRUG MARKETING ASSOCIATION INC | 4005f8dd-3050-4590-8703-6997444e8df3 | 2025-08-13 | Warnings | M013 |
| good sense headache relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 4cae0580-7ee3-4f38-8d13-79c7d7615f8f | 2025-08-12 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 3bb7dc60-97b2-1291-e063-6294a90a26d9 | 2025-08-12 | Warnings | M013 |
| Dr Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Farmacias De Similares TX LLC | 3c19ad99-6e0f-3116-e063-6394a90a914c | 2025-08-11 | 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 |