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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | HHH Pharmaceuticals | 0c66b05d-132d-4c79-abfe-415fd68bbb9c | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Better Living Brands, LLC | 5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24 | 2026-05-06 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Geiss, Destin & Dunn Inc. | b8f6e486-5332-4c46-ab6c-7de04c91c60b | 2026-05-06 | Warnings | M013 |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | c60494f0-5a50-41da-bcb4-88178ded54b7 | 2026-05-05 | Warnings | M013 |
| equate pain relief pm | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 85129749-c1a7-4c4a-933f-c3c4768e2cdd | 2026-05-05 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | f3feca65-adc1-469f-bef6-12c860599abe | 2026-05-04 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 4dda3534-4e83-447b-be75-33dadce06c47 | 2026-05-04 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | Major Pharmaceuticals | 4ba6eed3-004a-4576-b7f7-685fae49cf6a | 2026-05-04 | Warnings | M013 |
| Back and Body | ASPIRIN, CAFFEINE | Kroger Company | 366b58db-1ac3-427b-b42a-5f56a14e298c | 2026-05-01 | Warnings | M013 |
| Tylenol PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 2026-05-01 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Savings Distributors LLC | 8ed90757-833e-f4d9-e053-2995a90a29db | 2026-05-01 | Warnings | M013 |
| Acetaminophen , Aspirin and Caffeine | ACETAMINOPHEN , ASPIRIN AND CAFFEINE | Softgel Healthcare Pvt Ltd | 4543e156-1deb-666e-e063-6394a90a719c | 2026-04-27 | Warnings | M013 |
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 45478958-ad86-4d87-e063-6394a90a3c45 | 2026-04-27 | Warnings | M013 |
| Medique at Home Aspirin | ASPIRIN | Sportpharm LLC | 0f2aa75e-534f-478b-811e-fb492b7af9bb | 2026-04-24 | Warnings | M013 |
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Sportpharm LLC | cc280926-ad94-4017-a04a-b4315807eacb | 2026-04-24 | Warnings | M013 |
| Aspirin | ASPIRIN | Health Pharma USA LLC | 503868bb-48e0-b718-e063-6394a90a9c5b | 2026-04-24 | Warnings | M013 |
| BC CHERRY | ASPIRIN AND CAFFEINE | Medtech Products Inc. | c5fa6660-a549-49ff-ac2b-5799afa22ec5 | 2026-04-24 | Warnings | M013 |
| Doans Maximum Strength | MAGNESIUM SALICYLATE | Dr. Reddy's Laboratories Inc. | c906df41-bb45-03ea-b1a8-2b9816d55c97 | 2026-04-24 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 48912649-9fa1-a11f-e063-6294a90a8a72 | 2026-04-23 | 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 |