Pain Relief PM
- Product NDC
- 42507-095
- 11-digit product format
- 425070095
- Labeler code
- 42507
- Product ID
- 42507-095_440cb853-1454-0cda-e063-6294a90a73a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Diphenhydramine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- HYVEE INC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-22
- 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
- 2026-12-31
- 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 Relief PM
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 3e60703b-a5cf-333a-e063-6394a90a2087 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-095-03 | Pain Relief PM | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 42507-095-03 | Pain Relief PM | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 3 | |
| 42507-095-17 | Pain Relief PM | 225 in 1 BOTTLE, PLASTIC | TABLET, COATED | 225 | 3 |
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 |
|---|---|---|---|---|---|---|
| dg health pain relief | ACETAMINOPHEN | Dolgencorp, LLC | 382fa2cc-1c39-4bee-b528-08b11ec945af | 2024-11-02 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | f7e20527-1d4b-434c-997b-3eb8211fdaa1 | 2024-11-01 | Warnings | M013 |
| Aspirin Enteric Safety Coated | ASPIRIN | Publix Supermarkets, Inc. | a661a9ed-9b31-46b1-aafb-61d1ba8a4918 | 2024-11-01 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | 614e69c7-d3cb-4d47-9603-c1c14b87544c | 2024-11-01 | Warnings | M013 |
| infants fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | baee03b8-fcfd-440e-90ea-1ee2a18516ef | 2024-11-01 | Warnings | M013 |
| good neighbor pharmacy infants pain and fever | ACETAMINOPHEN | Amerisource Bergen | bfb954b7-3a79-4bca-95e8-d39e1074b07f | 2024-11-01 | Warnings | M013 |
| EXTRA STRENGTH PAIN RELIEVER | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Proficient Rx LP | bf365bfc-35cc-47f9-a50b-ff2b38d7316b | 2024-11-01 | Warnings | M013 |
| Infants Pain Relief | ACETAMINOPHEN | Publix Super Markets Inc | 0bc33897-afc2-4d11-be6c-a26480f448bf | 2024-10-31 | Warnings | M013 |
| equate infants pain and fever | ACETAMINOPHEN | WALMART INC. | 34b2512e-743b-45db-92cb-ea05e2f47b3d | 2024-10-31 | Warnings | M013 |
| foster and thrive infants pain and fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 45770ad6-9bf7-41bd-a724-e5260cd31fa1 | 2024-10-31 | Warnings | M013 |
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET | Lil' Drug Store Products, Inc. | d20425a4-f074-4154-e053-2995a90ae9fd | 2024-10-30 | Warnings | M013 |
| up and up infants acetaminophen | ACETAMINOPHEN | Target Corporation | 31104956-04d7-41b5-82be-219ded5c02a9 | 2024-10-30 | Warnings | M013 |
| Sunmark Aspirin | ASPIRIN | Strategic Sourcing Services LLC | a7139686-b351-47dc-a395-832429aaa569 | 2024-10-30 | Warnings | M013 |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1 | 2024-10-30 | Warnings | M013 |
| Acetaminophen | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | M013 |
| Junior Acetaminophen Ages 6-11 | ACETAMINOPHEN | Chain Drug Consortium | d356bc9c-66f1-45c3-a455-98c0b8890f78 | 2024-10-28 | Warnings | M013 |
| leader Acetaminophen | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 | 2024-10-25 | Warnings | M013 |
| GOODYS PM | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | Medtech Products Inc. | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b | 2024-10-25 | Warnings | M013 |
| Goodys Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 16d774cc-4247-4bf8-9b5a-c338ffebda3d | 2024-10-25 | Warnings | M013 |
| aspirin | ASPIRIN | PUBLIX SUPER MARKETS INC | 9e77ab7a-07e8-42aa-e053-2995a90a0d0e | 2024-10-24 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 3e60703b-a5cf-333a-e063-6394a90a2087 | 3 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 3e60703b-a5cf-333a-e063-6394a90a2087 | 3 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 3e60703b-a5cf-333a-e063-6394a90a2087 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42507-095-03 | 42507009503 | 1 BOTTLE, PLASTIC in 1 CARTON (42507-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2025-10-22 | No | No | Current |
| 42507-095-17 | 42507009517 | 225 TABLET, COATED in 1 BOTTLE, PLASTIC (42507-095-17) | 2025-11-20 | No | No | Current |