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 |
|---|---|---|---|---|---|---|
| Lil Drug Store Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | de59aae2-f794-4243-acc8-37a10e27abde | 2023-12-15 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN TABLET, EXTRA STRENGTH | Lil' Drug Store Products, Inc. | f0fdab5a-9d07-57aa-e053-2a95a90adc7f | 2023-12-15 | Warnings | M013 |
| BC Cherry | ASPIRIN AND CAFFEINE | Lil' Drug Store Products, Inc | 79ea721b-d656-44f7-9d13-390debee7be0 | 2023-12-15 | Warnings | M013 |
| Alka-Seltzer | BUFFERED ASPIRIN | Lil' Drug Store Products, Inc. | 0c7a60e7-0bde-9aa2-e063-6294a90a3209 | 2023-12-14 | Warnings | M013 |
| Circle K Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | 4cd306e3-2119-4272-9da4-a848fe2746fa | 2023-12-14 | Warnings | M013 |
| Circle K Pain Reliever Extra Strength | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | f2359bc3-901f-4ecb-b402-cb2fe404a935 | 2023-12-14 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | c55b8f9d-1396-43c0-acc9-5e3485eadb07 | 2023-12-08 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 775519ad-5683-451f-9bfc-5fafc70c68ec | 2023-12-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | WALGREEN CO. | c20c814b-35f5-4c46-e053-2a95a90a50f2 | 2023-12-08 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Better Living Brands LLC | f9859be4-6d0b-2ab8-e053-6294a90aa862 | 2023-12-06 | Warnings | M013 |
| Aurophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | b9b7b849-c3b3-9af7-e053-2a95a90a0077 | 2023-12-06 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | cf649478-57d2-cc88-e053-2a95a90ad1ba | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | KROGER COMPANY | b9b6f878-1ec8-3dc0-e053-2995a90a5414 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | cc939a7c-ce56-5dd6-e053-2995a90aa8af | 2023-12-06 | Warnings | M013 |
| Alka-Seltzer Original Flavor | BUFFERED ASPIRIN, EFFERVESCENT TABLET | Lil' Drug Store Products, Inc. | ea5df8be-a08c-5fa3-e053-2995a90a0bac | 2023-12-06 | Warnings | M013 |
| Ringl | ACETAMINOPHEN | Sato Pharmaceutical Co., Ltd. | ba5a0286-3e0f-4bef-96e5-29d92f51f432 | 2023-12-06 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 41633554-474e-4d3c-9187-d90487d2ae8c | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Family Dollar Stores, LLC | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 2023-12-05 | Warnings | M013 |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Pharmadel LLC | 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 | 2023-12-01 | 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 |