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 |
|---|---|---|---|---|---|---|
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Unifirst First Aid Corporation | b56b4110-fb8f-e5a0-e053-2995a90a0ad3 | 2025-09-08 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | 64c642b7-ef83-44b7-a014-6fa248dff3ba | 2025-09-08 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE | BJWC (Berkley & Jensen / BJ's) | 2f473f1f-7cf3-2af5-e063-6394a90aaa17 | 2025-09-01 | Warnings | M013 |
| foster and thrive rapid release pain relief | ACETAMINOPHEN | Strategic Sourcing Services LLC | d2130173-b107-4ae6-a1f7-6db467da3820 | 2025-08-30 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Precision Dose, Inc. | e1d4f562-433c-4344-9b77-1a7c731d1be5 | 2025-08-29 | Warnings | M013 |
| Aspirin Enteric Coated Low Dose | ASPIRIN | Walgreen Company | b11a4c4e-374c-403e-a757-5e9700f9f03b | 2025-08-27 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Safeway | 0e0a73f9-8c18-41fd-812e-8be20287e77a | 2025-08-26 | Warnings | M013 |
| Aspirin Low Dose Safety Coated | ASPIRIN | BJWC (Berkley & Jensen / BJ's) | 577035a5-88ab-431c-8598-7a19dd633fe9 | 2025-08-26 | Warnings | M013 |
| Topcare Pain Relief | ACETAMINOPHEN | Sixarp, LLC | 2e20be17-2b6c-1a07-e063-6394a90acdd3 | 2025-08-25 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | BJWC (Berkley & Jensen / BJ's) | 2f32b096-d29a-c7c7-e063-6294a90a2bbe | 2025-08-22 | Warnings | M013 |
| Medique Medi Seltzer | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Unifirst First Aid Corporation | 528da9d9-2a52-4c16-b7b2-61b3eee1abea | 2025-08-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Publix Super Markets Inc | 6b691dc1-09e4-46d3-b199-8917e42848a6 | 2025-08-19 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | P & L Development, LLC | 59eb14a5-40b0-4331-beb5-7166e6cdf411 | 2025-08-18 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | caf5daea-409e-5dd2-e053-2995a90acb12 | 2025-08-18 | Warnings | M013 |
| Dr Simi Pain Relief 100 | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c42e48d-cdb2-eb74-e063-6394a90a2940 | 2025-08-13 | Warnings | M013 |
| Dr Simi Pain Relief | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c477d33-a8c2-d39f-e063-6294a90ac5f0 | 2025-08-13 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | CHAIN DRUG MARKETING ASSOCIATION INC | 4005f8dd-3050-4590-8703-6997444e8df3 | 2025-08-13 | Warnings | M013 |
| good sense headache relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 4cae0580-7ee3-4f38-8d13-79c7d7615f8f | 2025-08-12 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 3bb7dc60-97b2-1291-e063-6294a90a26d9 | 2025-08-12 | Warnings | M013 |
| Dr Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Farmacias De Similares TX LLC | 3c19ad99-6e0f-3116-e063-6394a90a914c | 2025-08-11 | 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 |