Headache Relief
- Product NDC
- 59726-586
- 11-digit product format
- 597260586
- Labeler code
- 59726
- Product ID
- 59726-586_2cf01c31-a85c-4e59-9714-f3ba6be0443d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-20
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250; 250; 65 mg/1; 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
- Headache Relief
- Brand name suffix
- Extra Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
| 3G6A5W338E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308297 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55e996cd-ef22-4e09-a05c-8aa994e4540b | 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 |
|---|---|---|---|---|---|---|
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | M013 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | NuCare Pharmaceuticals,Inc. | 9e691264-d48a-6b48-e053-2995a90a9352 | 2024-06-20 | Warnings | M013 |
| Aspirin | REGULAR STRENGTH ENTERIC COATED ASPIRIN | NuCare Pharmceuticals,Inc. | a0705f4f-55cb-214a-e053-2995a90aa680 | 2024-06-20 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG | Lil' Drug Store Products, Inc. | ee8e0e79-4da4-101f-e053-2a95a90a30a4 | 2024-06-19 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 2024-06-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | 43c3fe72-a4ef-48a6-bc22-a644919c0c5c | 2024-06-17 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | 093182a6-3ed8-5a3f-e063-6294a90a354a | 2024-06-14 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 093199be-e92a-6f60-e063-6294a90a8533 | 2024-06-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | 09315a3d-bb2d-4f06-e063-6294a90a3bd3 | 2024-06-14 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 613bc633-0426-41a7-aea9-9ff56311b607 | 2024-06-13 | Warnings | M013 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 59726-586-80 | 59726058680 | 1 BOTTLE, PLASTIC in 1 BOTTLE (59726-586-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC | 2026-06-20 | No | No | Current |