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 Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | cfaf9495-e654-4dfc-ba23-d2358c3720c4 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 18ff2df8-ee65-4219-ad93-cf5090bfac2d | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | bfb9af64-3195-44bf-bcf3-6b36b40d3cc7 | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1ac7ed71-5afe-d09c-e063-6294a90a3b88 | 2024-06-13 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 3f73a359-59d7-47bb-872e-914b0db719af | 2024-06-13 | Warnings | M013 |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f1e940ef-3cf0-4a5c-8158-156d0e5a680d | 2024-06-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 7c73fc75-af9b-177c-e053-2a91aa0ada56 | 2024-06-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Topco Associates | 4a6a1dbb-c813-42fd-9bb8-497aec339466 | 2024-06-11 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | fa234639-caf8-4c52-9ffe-f1c0c057ee5b | 2024-06-10 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | bc18590d-6481-4efe-8a3b-974f7543b754 | 2024-06-10 | Warnings | M013 |
| ASPIRIN | ASPIRIN | H-E-B | 085b35db-62e4-38db-e063-6394a90a9763 | 2024-06-07 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | 5691ac45-5732-412e-abb8-2bfaac59160e | 2024-06-07 | Warnings | M013 |
| Cafiaspirina Rapid Headache Relief | ASPIRIN, CAFFEINE | Belmora LLC | d890acec-6528-4fb7-8d59-6c572a3f0786 | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | TARGET Corporation | 611bc1ce-460a-44a3-8e2d-b28a399d9a44 | 2024-06-06 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Meijer Distribution Inc | 033a6153-2651-4703-8a94-def461838113 | 2024-06-05 | 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 |