Xpect Pain Away Extra Strength
- Product NDC
- 42961-234
- 11-digit product format
- 429610234
- Labeler code
- 42961
- Product ID
- 42961-234_b7379830-65bc-4257-8915-b0f14f506e93
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Aspirin Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cintas Corporation
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-26
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250; 250; 65 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 42961-234 | 42961-234-02 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 42961-234 | 42961-234-03 | D | Discontinued by firm | 2026-10-21 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 42961-234-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 42961-234-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 42961-234-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 42961-234-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 42961-234-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 42961-234-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 42961-234-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 42961-234-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 42961-234-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 42961-234-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 42961-234-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 42961-234-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 42961-234-03 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 42961-234-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 42961-234-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 42961-234-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 42961-234-03 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 42961-234-02 | 0efc9e666f02… | f202fb6c5f17… |
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
- Xpect Pain Away Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
| 3G6A5W338E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308297 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1269d069-afaf-4ca5-b369-f74249a348db | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42961-234-01 | Xpect Pain Away Extra Strength | 2 in 1 PACKAGE | TABLET | 2 | 3 | |
| 42961-234-02 | Xpect Pain Away Extra Strength | 50 in 1 BOX | TABLET | 50 | 3 | |
| 42961-234-03 | Xpect Pain Away Extra Strength | 125 in 1 BOX | TABLET | 125 | 3 | |
| 42961-234-04 | Xpect Pain Away Extra Strength | 40 in 1 BOX | TABLET | 40 | 3 | |
| 42961-234-05 | Xpect Pain Away Extra Strength | 80 in 1 BOX | TABLET | 80 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Menstrual Relief Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | United Natural Foods, Inc. dba UNFI | 807598ef-9f03-48df-b076-3ee95ef4b06c | 2026-01-05 | Warnings | M013 |
| Pain Relief Extra Strength, Non-Aspirin | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 1fb5e871-45fd-46fe-bf73-5192f8316e8e | 2026-01-02 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Valu Merchandisers Company | 0005aafa-08f8-4990-a54d-cc097195708f | 2026-01-02 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | Walmart Inc. | 152bb455-da5b-ae13-e063-6394a90acab0 | 2026-01-01 | Warnings | M013 |
| Dr. Cocoa for Children Pain and Fever | ACETAMINOPHEN | Infirst Healthcare Inc. | 486ea294-6d18-a907-e063-6294a90ad284 | 2026-01-01 | Warnings | M013 |
| ED APAP | ACETAMINOPHEN | EDWARDS PHARMACEUTICALS, INC. | f76d5fff-ebea-40f9-aad3-4064a0c863f0 | 2025-12-31 | Warnings | M013 |
| EXTRA STRENGTH PAIN RELIEF | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 99ec63ef-aa28-c2fb-e053-2a95a90a9f6d | 2025-12-31 | Warnings | M013 |
| Puregen Labs Acetaminophen | ACETAMINOPHEN | Advanced Rx LLC | 474580af-f6b0-e440-e063-6394a90aaada | 2025-12-31 | Warnings | M013 |
| Liquid Acetaminophen | ACETAMINOPHEN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | a7dbd4c0-53eb-4368-917b-1432c09ce6b4 | 2025-12-31 | Warnings | M013 |
| Llorens Care Children Acetaminophen | ACETAMINOPHEN | Llorens Pharmaceutical International Division, Inc. | 2a46d7d2-293b-5024-e063-6294a90a31aa | 2025-12-31 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE) | Walgreens | 3a801457-c5d0-b134-e063-6294a90ac5cb | 2025-12-31 | Warnings | M013 |
| Daytime and Nighttime Severe Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Genexa Inc. | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2025-12-30 | Warnings | M013 |
| BioElectro Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Genomma Lab USA | 683a0fba-921c-48e7-a391-180c04f0d1c4 | 2025-12-30 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | 0181af13-da32-4431-be39-c31fdfac9202 | 2025-12-29 | Warnings | M013 |
| Gemma Cut the Cramp | ASPIRIN, CAFFEINE | Rally Labs LLC | 16c9a296-077a-8e12-e063-6294a90a1b8b | 2025-12-29 | Warnings | M013 |
| Blowfish | ASPIRIN, CAFFEINE | Rally Labs LLC | 0d3798bc-04ef-584e-821b-7aa76036b7d1 | 2025-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Pioneer Life Sciences, LLC | ac9efd62-8fee-b777-e053-2995a90a3783 | 2025-12-29 | Warnings | M013 |
| Childrens Pain Relief and Fever Reducer Oral Suspension Cherry | ACETAMINOPHEN | Puro Pharma Inc. | a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009 | 2025-12-27 | Warnings | M013 |
| Cystex PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Clarion Brands, LLC | 9668a2ca-729e-4172-80b5-33e6c5175ba4 | 2025-12-27 | 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 | 1269d069-afaf-4ca5-b369-f74249a348db | 3 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 1269d069-afaf-4ca5-b369-f74249a348db | 3 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 1269d069-afaf-4ca5-b369-f74249a348db | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42961-234-01 | 42961023401 | 2 in 1 PACKAGE | Historical | ||||
| 42961-234-02 | 42961023402 | 50 in 1 BOX | Historical | ||||
| 42961-234-03 | 42961023403 | 125 in 1 BOX | Historical | ||||
| 42961-234-04 | 42961023404 | 40 PACKAGE in 1 BOX (42961-234-04) / 2 TABLET in 1 PACKAGE (42961-234-01) | 40 package | 2024-12-27 | No | No | Current |
| 42961-234-05 | 42961023405 | 80 PACKAGE in 1 BOX (42961-234-05) / 2 TABLET in 1 PACKAGE (42961-234-01) | 80 package | 2024-12-27 | No | No | Current |