Acetaminophen PM
- Product NDC
- 41163-228
- 11-digit product format
- 411630228
- Labeler code
- 41163
- Product ID
- 41163-228_fe731291-4046-4366-96f7-2bcd869124f7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-08-29
- Marketing end
- 2027-11-28
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500; 25 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
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
- Acetaminophen PM
- Brand name suffix
- Extra Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 24173e77-92ec-4a87-a471-d6867837c180 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41163-228-50 | Acetaminophen PMExtra Strength | 1 in 1 BOX | TABLET, COATED | 1 | 9 | |
| 41163-228-50 | Acetaminophen PMExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41163-228 | ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250316_24173e77-92ec-4a87-a471-d6867837c180.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 |
|---|---|---|---|---|---|---|
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 17640528-c1f7-4881-ba86-bb3f488a952c | 2025-10-24 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | China Ningbo Shangge Cosmetics Technology Corp. | 33e259d6-b065-a677-e063-6394a90ab314 | 2025-10-23 | Warnings | M012 |
| Severe Nighttime Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 2025-10-23 | Warnings | M012 |
| Rycontuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 41afb883-1158-9764-e063-6294a90a1712 | 2025-10-21 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE | CVS Pharmacy, Inc | 1532ee21-e114-ded7-e063-6294a90ab025 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 1538bf63-d020-3ba2-e063-6294a90aecc5 | 2025-10-21 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 1539c3d4-d982-7d4e-e063-6394a90ad7d6 | 2025-10-21 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Method Pharmaceuticals, LLC | 312ce620-4841-7488-e054-00144ff88e88 | 2025-10-21 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Method Pharmaceuticals, LLC | 5a60c923-8bb7-427f-9636-08ed5474f71b | 2025-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 97ed70a0-b692-4c12-90d6-72b3c87e554c | 2025-10-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 311e2b6b-21cb-4b4c-a78d-a0732d29602f | 2025-10-21 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 13910ea1-37dd-43bb-9fe8-e843f59201b7 | 2025-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Amerisource Bergen | d6f185b6-8538-4eac-98da-83760c34b488 | 2025-10-20 | Warnings | M012 |
| Quantum Health Bing Cherry Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | 94d40c95-fa2b-42cf-b9f5-a5027d86401d | 2025-10-20 | Warnings | M012 |
| Quantum Health Meyer Lemon and Honey Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | fe780067-5a20-4d55-a108-91237cd9e5f4 | 2025-10-20 | Warnings | M012 |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 2025-10-17 | Warnings | M012 |
| Norel AD | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL | U.S. PHARMACEUTICAL CORPORATION | 53d9ed3c-212d-4b12-ac35-8bd49382b49d | 2025-10-17 | Warnings | M012 |
| Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 92c570ff-139f-49ff-a7bd-8a540ecc07c7 | 2025-10-17 | Warnings | M012 |
| NoHist DM | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 6aafe912-28ff-442f-8e07-b3c5993ac943 | 2025-10-16 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 24173e77-92ec-4a87-a471-d6867837c180 | 9 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 24173e77-92ec-4a87-a471-d6867837c180 | 9 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 24173e77-92ec-4a87-a471-d6867837c180 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41163-228-50 | 41163022850 | 1 BOTTLE, PLASTIC in 1 BOX (41163-228-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2014-08-29 | 2027-11-28 | No | No | Current |