EXTRA STRENGHT HEADACHE RELIEF
- Product NDC
- 68210-0107
- 11-digit product format
- 682100107
- Labeler code
- 68210
- Product ID
- 68210-0107_ee51505c-d965-9fb7-e053-2a95a90a2399
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Spirit Pharmaceutical LLC
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2020-03-10
- 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 | 68210-0107 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 68210-0107 | 68210-0107-1 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 68210-0107 | 68210-0107-3 | I | Inactivated by FDA | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-0107-1 | 2026-01-29 | C162847 | 48780-1 | 49896155-b645-586f-e063-e6dba90add90 | EXTRA STRENGTH HEADACHE RELIEF |
| 68210-0107-3 | 2026-01-29 | C162847 | 48780-1 | 49896155-b645-586f-e063-e6dba90add90 | EXTRA STRENGTH HEADACHE RELIEF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0107-1 | EXTRA STRENGHT HEADACHE RELIEF | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 68210-0107-1 | EXTRA STRENGHT HEADACHE RELIEF | 1 in 1 CARTON | TABLET | 1 | 8 | |
| 68210-0107-3 | EXTRA STRENGHT HEADACHE RELIEF | 300 in 1 PACKAGE | TABLET | 300 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0107 | EXTRA STRENGHT HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [SPIRIT PHARMACEUTICAL LLC] | 8 | Legacy NDC, 3 package rows | 20250101_0ef44587-c160-403f-b8a6-8bedf8e2eb8e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 9 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 9 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 9 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 0ef44587-c160-403f-b8a6-8bedf8e2eb8e | 8 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 0ef44587-c160-403f-b8a6-8bedf8e2eb8e | 8 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 0ef44587-c160-403f-b8a6-8bedf8e2eb8e | 8 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 | 6 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 | 6 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 | 6 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | d18e1631-de43-4b29-e053-2995a90af56d | 5 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | d18e1631-de43-4b29-e053-2995a90af56d | 5 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | d18e1631-de43-4b29-e053-2995a90af56d | 5 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | e711ff0a-2fa0-1f2a-e053-2a95a90a4e38 | 3 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | e711ff0a-2fa0-1f2a-e053-2a95a90a4e38 | 3 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | e711ff0a-2fa0-1f2a-e053-2a95a90a4e38 | 3 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 0c41deda-490b-f5d2-e063-6394a90a5047 | 2 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 0c41deda-490b-f5d2-e063-6394a90a5047 | 2 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 0c41deda-490b-f5d2-e063-6394a90a5047 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68210-0107-1 | 68210010701 | 1 BOTTLE in 1 CARTON (68210-0107-1) > 100 TABLET in 1 BOTTLE | 1 bottle | 2020-03-10 | 0000-00-00 | No | No | Current |
| 68210-0107-3 | 68210010703 | 300 TABLET in 1 PACKAGE (68210-0107-3) | 300 tablet | 2020-03-10 | 0000-00-00 | No | No | Current |