Excedrin Extra Strength and Excedrin Tension Headache
- Product NDC
- 0067-8151
- 11-digit product format
- 000678151
- Labeler code
- 0067
- Product ID
- 0067-8151_4b80ea7d-b5ef-e06c-e063-6294a90aafac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin (NSAID), and Caffeine
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-09-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | 0067-8151 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0067-8151 | 0067-8151-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… |
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
- Excedrin Extra Strength and Excedrin Tension Headache
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2c8df1c7-7864-48df-939c-d9ae22e0f52c | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8151-01 | 2023-03-28 | C162847 | 48780-1 | e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4e | Drug Facts |
| 0067-8151-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b2f2-d8a0-e053-dadaa90a6e4e | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-2000-91 | Excedrin Extra Strength and Excedrin Tension Headache | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 65 mg | 5 |
| 0067-2000-91 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 CARTON | TABLET, FILM COATED | 65 mg | 5 | |
| 0067-8139-01 | Excedrin Extra Strength and Excedrin Tension Headache | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 500 mg | 5 |
| 0067-8139-01 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 CARTON | TABLET, FILM COATED | 65 mg | 5 | |
| 0067-8151-01 | Excedrin Extra Strength and Excedrin Tension Headache | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8151 | EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE (ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE) KIT [HALEON US HOLDINGS LLC] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240315_2c8df1c7-7864-48df-939c-d9ae22e0f52c.zip |
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 | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | PSN | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 404172 | EXCEDRIN TENSION HEADACHE 500 MG / 65 MG Oral Tablet | PSN | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 404172 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet [Excedrin Tension Headache] | SBD | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | SCD | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 307686 | APAP 500 MG / Caffeine 65 MG Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 404172 | APAP 500 MG / Caffeine 65 MG Oral Tablet [Excedrin Tension Headache] | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 404172 | Excedrin Aspirin Free (acetaminophen 500 MG / caffeine 65 MG) Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
| 404172 | Excedrin Tension Headache (APAP 500 MG / caffeine 65 MG) Oral Tablet | SY | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-2000-91 | 00067200091 | 100 in 1 BOTTLE | Historical | |||||
| 0067-8139-01 | 00067813901 | 24 in 1 BOTTLE | Historical | |||||
| 0067-8151-01 | 00067815101 | 1 KIT in 1 PACKAGE, COMBINATION (0067-8151-01) * 1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 kit | 2018-09-30 | 0000-00-00 | No | No | Current |