Headache Relief
- Product NDC
- 69168-285
- 11-digit product format
- 691680285
- Labeler code
- 69168
- Product ID
- 69168-285_8db7fab3-4274-49e6-856c-ce55e7c84dcf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin and Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-02-15
- 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
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 package | package | 69168-285 | 69168-285-24 | D | Discontinued by firm | 2026-10-15 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2020-03-13 | Drug Facts |
| 2020-03-13 | Drug Facts |
| 2020-03-13 | Drug Facts |
| 2020-03-13 | Drug Facts |
| 2020-01-31 | Drug Facts |
| 2020-01-31 | Drug Facts |
| 2020-01-31 | Drug Facts |
| 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-285-24 | Headache ReliefExtra Strength | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 4 | |
| 69168-285-24 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 | |
| 69168-285-37 | Headache ReliefExtra Strength | 16 in 1 BOTTLE | TABLET, FILM COATED | 16 | 4 | |
| 69168-285-37 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Bayer Rapid Relief | ASPIRIN/CAFFEINE ORAL POWDER | Bayer HealthCare LLC. | f1fecbb0-5b55-fe8f-e053-2995a90a0977 | 2025-12-05 | Warnings | M013 |
| Headache Relief, Extra Strength 24/7 Life by 7-Eleven | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 45381b1c-2acd-1524-e063-6394a90a83d9 | 2025-12-05 | Warnings | M013 |
| Acetaminophen Easy Tabs Extra Strength | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | 729132cd-f209-447a-8949-a90b5a5c01da | 2025-12-05 | Warnings | M013 |
| Menstrual Pain Relief Complete | ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE | Shield Pharmaceuticals Corp | 05fda811-d65f-41b2-89e4-297cdddb3d99 | 2025-12-05 | Warnings | M013 |
| aspirin | ASPIRIN | Health Pharma USA, LLC | 3165b0a3-556b-6abe-e063-6394a90a7682 | 2025-12-04 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Bayer HealthCare LLC. | 44a08904-68b9-4d06-a28d-21aae3d6140c | 2025-12-04 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a29dde6-a177-6206-e053-2991aa0a01f2 | 2025-12-04 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7570aaa2-3238-4cd3-b788-915caa970dba | 2025-12-04 | Warnings | M013 |
| Bayer Headache | ASPIRIN AND CAFFEINE | Bayer HealthCare LLC. | c0a92873-0914-6a86-e053-2995a90ac41c | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Bayer HealthCare LLC. | 07478020-5ba0-3b67-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0dba1329-5b0d-5688-e054-00144ff8d46c | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Plus Cold Medicine Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 78537dcf-b157-4b67-a8b2-5cb144815166 | 2025-12-04 | Warnings | M013 |
| BAYER Aspirin Extra Strength Caplets | BAYER ASPIRIN EXTRA STRENGTH | Bayer HealthCare LLC. | 0ae64cdb-4ea0-23af-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored | ASPIRIN | Bayer HealthCare LLC. | 070d5713-e018-2913-e054-00144ff8d46c | 2025-12-04 | Warnings | M013 |
| Bayer Low Dose | ASPIRIN | Bayer HealthCare LLC. | 075b103e-0bb4-4b7a-ac0e-5645bcbd0a07 | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc | 2025-12-04 | Warnings | M013 |
| Bayer Aspirin Regimen enteric coated | ASPIRIN | Bayer HealthCare LLC. | 0c6ae05f-7634-34d1-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| aspirin pain relief | ASPIRIN | Rite Aid Corporation | ae9d9977-7576-4894-8a32-454828abec9a | 2025-12-04 | Warnings | M013 |
| ASPIRIN | ASPIRIN | RMT HEALTH LLC | 2bacffd1-4870-73af-e063-6294a90a19c8 | 2025-12-02 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rite Aid Corporation | d9caee45-be43-45ec-927f-e7fec5c14f07 | 2025-12-02 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 6197eff5-0351-42ef-bb3f-cbc26e6d0d14 | 4 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 6197eff5-0351-42ef-bb3f-cbc26e6d0d14 | 4 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 6197eff5-0351-42ef-bb3f-cbc26e6d0d14 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69168-285-24 | 69168028524 | 1 BOTTLE in 1 CARTON (69168-285-24) > 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2010-02-15 | 2024-03-31 | No | No | Current |
| 69168-285-26 | 69168028526 | 1 BOTTLE in 1 CARTON (69168-285-26) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-03-06 | No | No | Current | |
| 69168-285-37 | 69168028537 | 1 BOTTLE in 1 CARTON (69168-285-37) / 16 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-09-08 | 0000-00-00 | No | No | Current |