Pain Reliever PM
- Product NDC
- 55319-562
- 11-digit product format
- 553190562
- Labeler code
- 55319
- Product ID
- 55319-562_1dc1bd15-bee3-4602-9687-5b2e1d55c00a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-01
- 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
- Listing certified through
- 2027-12-31
- 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
- Pain Reliever PM
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 7a98d4d9-54e2-45c1-a76a-7f1907566e95 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-562-10 | Pain Reliever PM | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 7 | |
| 55319-562-10 | Pain Reliever PM | 1 in 1 BOX | TABLET, COATED | 1 | 7 | |
| 55319-562-24 | Pain Reliever PM | 24 in 1 BOTTLE, PLASTIC | TABLET, COATED | 24 | 7 | |
| 55319-562-24 | Pain Reliever PM | 1 in 1 BOX | TABLET, COATED | 1 | 7 | |
| 55319-562-50 | Pain Reliever PM | 1 in 1 BOX | TABLET, COATED | 1 | 7 | |
| 55319-562-50 | Pain Reliever PM | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 7 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Westminster Pharmaceuticals, LLC | ace5ebac-ec11-4c26-b1e3-954b450ee671 | 2021-05-04 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 8cacf02c-9925-40d4-92bc-78788aa0681a | 2020-11-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN 500 MG | Allegiant Health | 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7 | 2020-03-13 | Warnings | M013 |
| Acetaminophen 500mg ES | ACETAMINOPHEN 500MG | Allegiant Health | 91acc132-01b6-467b-9af5-70f4dc93e087 | 2019-01-08 | Warnings | M013 |
| Acetaminophen 325mg RS | ACETAMINOPHEN 325MG | Allegiant Health | 61c6d281-e59b-4277-bbce-f71c12c2a56d | 2019-01-07 | Warnings | M013 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Allegiant Health | 9a4c0c43-a71a-4e22-a3d5-9eb9622689a2 | 2019-01-02 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | 423a8445-964c-4cdb-889a-f391ca5253e7 | 2018-12-31 | Warnings | M013 |
| Cold Multi-Symptom Night-time | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI | Allegiant Health | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 2018-12-26 | Warnings | M013 |
| Aspirin Chewable | ASPIRIN 81 MG | Allegiant Health | 92b8637b-03a9-461f-b2f6-6eddaa214953 | 2018-12-21 | Warnings | M013 |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Allegiant Health | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 2018-12-21 | Warnings | M013 |
| Clear Choice Regular Strength Pain Reliever | ACETAMINOPHEN | Athlete's Needs, Inc. | d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 | 2018-12-11 | Warnings | M013 |
| ASPIRIN Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 5910a882-eb40-440f-8a30-c21fbce9050e | 2018-11-07 | Warnings | M013 |
| Aspirin | ASPIRIN 325 MG | Allegiant Health | 88b54062-8b3d-4024-a957-62b3255184b9 | 2018-11-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 | 2018-11-07 | Warnings | M013 |
| Tension Headache Relief | TENSION HEADACHE RELIEF | Allegiant Health | b431a1a3-39c4-4d6c-afdc-c8b017ad89da | 2017-11-16 | Warnings | M013 |
| SED-MAX | ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG | Command Brands, LLC | 4920a0e9-6f88-4df0-8657-77c95a3b9617 | 2017-01-19 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 55319-562-10 | 55319056210 | 1 BOTTLE, PLASTIC in 1 BOX (55319-562-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-07-01 | No | No | Current |
| 55319-562-24 | 55319056224 | 1 BOTTLE, PLASTIC in 1 BOX (55319-562-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-07-01 | No | No | Current |
| 55319-562-50 | 55319056250 | 1 BOTTLE, PLASTIC in 1 BOX (55319-562-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-07-01 | No | No | Current |