Headache Relief
- Product NDC
- 36800-525
- 11-digit product format
- 368000525
- Labeler code
- 36800
- Product ID
- 36800-525_a40e239e-8b06-4e21-b1f2-f32fe118a188
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-07-15
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 36800-525 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 36800-525 | 36800-525-10 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 36800-525-10 | 36800052510 | 1 BOTTLE, PLASTIC in 1 BOX (36800-525-10) > 100 TABLET in 1 BOTTLE, PLASTIC | 2016-07-15 | 0000-00-00 | No | No | Current |