Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever
- Product NDC
- 0067-8148
- 11-digit product format
- 000678148
- Labeler code
- 0067
- Product ID
- 0067-8148_4b80de14-ddcc-e314-e063-6394a90aaa0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-05-01
- 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 | 0067-8148 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0067-8148 | 0067-8148-01 | 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 PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 444fa225-c204-45d1-b3b3-aa5650ee5d07 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8148-01 | 2023-11-13 | C162847 | 48780-1 | e4f33bdf-aa52-d8a0-e053-dadaa90a6e4e | Drug Facts |
| 0067-8148-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aa52-d8a0-e053-dadaa90a6e4e | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-2000-91 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 250 mg | 6 |
| 0067-2000-91 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 65 mg | 6 | |
| 0067-2056-24 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | 24 in 1 BOTTLE | TABLET, COATED | 24 | 250 mg | 6 |
| 0067-2056-24 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | 1 in 1 CARTON | TABLET, COATED | 38 mg | 6 | |
| 0067-8148-01 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8148 | EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE) KIT [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240316_444fa225-c204-45d1-b3b3-aa5650ee5d07.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2047428 | {100 (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]) / 24 (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]) } Pack [Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever] | BPCK | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 2047427 | {100 (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet) } Pack | GPCK | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 2047427 | 100 daytime (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 nighttime (acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet) Kit | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593110 | acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593116 | Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral Tablet | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 2047428 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever Kit | PSN | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin] | SBD | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593116 | acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action] | SBD | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593110 | acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet | SCD | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 2047427 | 100 daytime (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet) / 24 nighttime (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet) Kit | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin] | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593110 | APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593116 | APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [Excedrin PM Triple Action] | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 209468 | Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 1593116 | Excedrin PM Triple Action (acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG) Oral Tablet | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
| 2047428 | Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever Kit | SY | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 6 |
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 | |||||
| 0067-2056-24 | 00067205624 | 24 in 1 BOTTLE | Historical | |||||
| 0067-8148-01 | 00067814801 | 1 KIT in 1 PACKAGE, COMBINATION (0067-8148-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 kit | 2018-05-01 | 0000-00-00 | No | No | Current |