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 |
|---|---|---|---|---|---|---|
| Extra Strength TYLENOL Cold Plus Flu Multi-Action Day | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold Plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ce43e5c2-fe96-4462-882c-d7479318b33d | 2024-11-07 | Warnings | M012 |
| TYLENOL SINUS PLUS HEADACHE DAY | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e608d214-cc46-4a24-ac85-1040e36e7403 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | e83f7911-22b4-4ffc-8f49-68f6acd2ebf5 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE. | Kenvue Brands LLC | f81d924e-10e9-0e9d-e053-6294a90a2ddf | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8b516736-86ac-47cb-a0ec-038d4c3a0020 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold plus Flu plus Cough Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e85e5eb9-3ecf-4784-999e-111e38e306f5 | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ef8a846d-4b29-4fd8-a683-fada04d0a2b9 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 9761c807-75a1-4498-a8c6-1f2b1c9ffde6 | 2024-11-07 | Warnings | M012 |
| TYLENOL Cold Plus Mucus Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 2024-11-07 | Warnings | M012 |
| Primatene | EPHEDRINE HYDROCHLORIDE | Foundation Consumer Brands | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2024-11-07 | Warnings | M012 |
| Rompe Pecho Max Multi Symptoms | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN | EFFICIENT LABORATORIES INC | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 | 2024-11-07 | Warnings | M012 |
| topcare sinus nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | ca1fefed-e9d7-430a-9da4-972b1a6fb786 | 2024-11-07 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | dd82a389-9ec5-4b3f-a9ea-1a56871ebd17 | 2024-11-07 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 1a8e2e03-e11b-4da1-945b-e2caadea7243 | 2024-11-07 | Warnings | M012 |
| SUDOGEST NASAL DECONGESTANT | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 2024-11-07 | Warnings | M012 |
| up and up childrens allergy melts | DIPHENHYDRAMINE HCL | Target Corporation | f98d1d54-8e11-4bb1-825a-ab5447d37847 | 2024-11-07 | Warnings | M012 |
| good sense severe day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 44130a1b-63cc-42ac-9590-fdf21a12d164 | 2024-11-07 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | a5ff1134-8985-4585-8e61-a5fd5f60afeb | 2024-11-07 | 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 |