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 Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6fee238-0b6f-cb84-e053-2995a90a361b | 2024-12-05 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | L.N.K. International, Inc. | 379ef03c-3b6a-40c3-b736-99f0537d26c8 | 2024-12-05 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Marc Glassman, Inc. | 43bf297f-2832-424f-a013-4bfa1d6c03e6 | 2024-12-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Precision Dose, Inc. | 5a68ab98-720c-479a-a60a-4e594add6c09 | 2024-12-04 | Warnings | M013 |
| HEB Effervescent Pain Relief | ASPIRIN | H. E. BUTT GROCERY COMPANY | 03876c71-60ec-3280-e063-6294a90a62dc | 2024-12-03 | Warnings | M013 |
| Migrafein FORTE | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 028875c9-4129-ce2c-e063-6294a90a26cc | 2024-12-03 | Warnings | M013 |
| Neo-Lubrina Fuerte | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 0288a327-fd4b-1991-e063-6294a90ace50 | 2024-12-03 | Warnings | M013 |
| CAFIZETAMOL FORTE | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 028771d3-a514-f7a5-e063-6394a90ac4f3 | 2024-12-03 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 048c4b03-1cf4-b724-e063-6294a90a1cad | 2024-12-03 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | TopCo Associates LLC | ecd6df7e-e7e2-446b-85ef-25971281fe31 | 2024-12-03 | Warnings | M013 |
| Market Basket Effervescent Pain Relief | ASPIRIN | DEMOULAS SUPER MARKETS, INC. | 08133bf0-3c8f-e4d0-e063-6294a90af79a | 2024-12-03 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | WinCo Foods, LLC | 4359da13-e851-440b-91b9-6b544bff20d2 | 2024-12-03 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | WinCo Foods, LLC | 5b3e8a78-5357-42ad-811e-b2578b25dc7b | 2024-12-03 | Warnings | M013 |
| Low Strength Chewable Aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | cc77b9d1-7874-4ce8-a763-3a0e1c2891de | 2024-12-03 | Warnings | M013 |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | c6b79501-d08b-4430-9545-70da5f545975 | 2024-12-03 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association | 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 | 2024-12-02 | Warnings | M013 |
| St. Joseph Chewable Low Dose Aspirin | ASPIRIN | Foundation Consumer Healthcare LLC | 248cd302-e380-4837-bdae-9df620b67e8a | 2024-12-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | 2024-12-02 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 409b5fcd-5880-4dda-85d8-26aeceb4f8ab | 2024-12-02 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | c0c31523-c4c5-43c2-8d72-4d1456c720e9 | 2024-12-02 | 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 |