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 |
|---|---|---|---|---|---|---|
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | 64c28b38-23bb-4c7e-9c19-1d1f0d597528 | 2024-01-18 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | e0dd4c04-6811-38a1-e053-2995a90aa3c9 | 2024-01-17 | Warnings | M013 |
| Regular Strength Acetaminophen | ACETAMINOPHEN | CARDINAL HEALTH | bdf8c511-ce25-0e30-e053-2a95a90a33f6 | 2024-01-10 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2560126e-a54a-4a47-9631-a1bca42f5277 | 2024-01-10 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | A-S Medication Solutions | ee4451c9-4d0f-4373-8f64-fcc1f9dd5856 | 2024-01-05 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 51ba690e-d76b-41c6-a083-8bc803e1faa2 | 2024-01-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin Extra Strength | ACETAMINOPHEN | Proficient Rx LP | 9071b047-5463-4f65-b775-bfb0ce066527 | 2024-01-01 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | TIME CAP LABORATORIES, INC | 1acc8c1a-c746-4635-800c-de1ad758fce0 | 2023-12-30 | Warnings | M013 |
| MAX Cold, Flu, and Sore Throat | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL | H E B | 9b09b660-0758-48dc-84c9-26cdd2aacc03 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | eb24323f-82a1-4ba3-9359-fe81571c3fba | 2023-12-29 | Warnings | M013 |
| Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | e6c3e545-b2ad-47f0-8318-c134a8e24f5b | 2023-12-29 | Warnings | M013 |
| Daytime Non-Drowsy COLD/FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Salado Sales, Inc. | e181b371-78c7-4163-865d-acc064be33ca | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever Cherry flavor | ACETAMINOPHEN | Walgreen Company | 64c65244-f7a3-401b-b83a-bf66d45268e2 | 2023-12-29 | Warnings | M013 |
| Nite-Time COLD/FLU ORIGINAL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | fcd24753-b42b-4d05-8379-0ec0351ab217 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0 | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever, Grape flavor | ACETAMINOPHEN | Walgreen Company | 0995d69f-61aa-40b0-b095-bb8595caf773 | 2023-12-29 | Warnings | M013 |
| DAY-TIME Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | ce900e42-d0c8-408d-a1c3-3a9bef1c97ee | 2023-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | DOLGENCORP, INC. | 06553550-5685-f3c3-e063-6394a90aef07 | 2023-12-22 | Warnings | M013 |
| Tension Headache Pain Relieving Aid | ACETAMINOPHEN,CAFFEINE | WAL-MART STORES INC | 00fadd26-a6eb-dc5e-e063-6394a90a3cca | 2023-12-15 | Warnings | M013 |
| Dye-Free Aspirin 81 | ASPIRIN | WALGREENS | d71a9d3a-cd28-14a8-e053-2995a90a832b | 2023-12-15 | 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 |