Acetaminophen
- Product NDC
- 57237-347
- 11-digit product format
- 572370347
- Labeler code
- 57237
- Product ID
- 57237-347_ffbb6e36-399b-40eb-96b4-b0406c712c0d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-09
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- 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
- Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f8237772-7656-49fb-b1de-f8fcb5fa55ee | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-347-01 | Acetaminophen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 | |
| 57237-347-05 | Acetaminophen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-347-01 | EA - Each | 57237-347 | 4f6789ab-9c2c-4ac7-a464-2a6e97d0c88b | 1 | 2025-08-11 |
| 57237-347-05 | EA - Each | 57237-347 | 87c5b2bc-2c08-4480-8a77-b1524ea59b13 | 1 | 2025-11-13 |
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 |
|---|---|---|---|---|---|---|
| Sleep Aid Plus Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | e3929179-dad2-4f7e-a971-dbf80f2b5e1b | 2026-06-08 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Pinnacle RX LLC | 53c11fb4-ba31-b5e5-e063-6394a90a9c1a | 2026-06-08 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | 9655c38a-126b-459e-b31d-0aa33d9eb522 | 2026-06-08 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | dce938f5-eeba-4a76-9261-2b1324c39a31 | 2026-06-08 | Warnings | M013 |
| Childrens Mapap | ACETAMINOPHEN | Bryant Ranch Prepack | 69c90cc8-846a-42cf-933a-108671689e8f | 2026-06-05 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Rugby Laboratories | 63fcd93a-b1db-44ba-8f2b-055a7deb205d | 2026-06-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ASCLEMED USA INC. | 707a9ea7-8f4e-4274-97bd-b8071a0ee06b | 2026-06-04 | Warnings | M013 |
| Aspirin Adult low dose | ACETYLSALICYCLIC ACID | Medline Industries, LP | 6dd6501f-841c-4994-e053-2a91aa0ae231 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5e6f2a-e813-0666-e053-6394a90a66a7 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5d92c2-4bbe-8ad1-e053-6294a90a65b6 | 2026-06-04 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Unit Dose Solutions, Inc. | 537219ac-552a-a30e-e063-6394a90aa9d1 | 2026-06-04 | Warnings | M013 |
| Pain Relief childrens | ACETAMINOPHEN | CVS PHARMACY | ff878f56-125a-4de7-b063-029f7030733d | 2026-06-04 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | CVS Pharmacy | 749e2be2-594a-4052-8fa5-45c9ade2d23c | 2026-06-03 | Warnings | M013 |
| Childrens Mapap | ACETAMINOPHEN | Major Pharmaceuticals | efec6af2-8b26-47f6-88c8-b0a6d69a2d7d | 2026-06-03 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | ae3114c3-8cfe-4b81-8ac7-c281fe68b462 | 2026-06-03 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | COSTCO WHOLESALE CORPORATION | 3745aa18-a711-43ed-9bc4-1f087b3c53c0 | 2026-06-03 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 3f653262-b931-7d42-e063-6394a90adddd | 2026-06-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreen Company | 0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4 | 2026-06-03 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 42310898-cf3a-4ffb-88bb-b8b84449156e | 2026-06-02 | Warnings | M013 |
| PAIN RELIEF | ACETAMINOPHEN | Meijer, Inc. | 1319bab8-8f17-44fb-9d91-099b0ba38a8d | 2026-06-01 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | f8237772-7656-49fb-b1de-f8fcb5fa55ee | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | f8237772-7656-49fb-b1de-f8fcb5fa55ee | 2 |
| 198440 | APAP 500 MG Oral Tablet | SY | f8237772-7656-49fb-b1de-f8fcb5fa55ee | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 57237-347-01 | 57237034701 | 100 TABLET, FILM COATED in 1 BOTTLE (57237-347-01) | 2025-07-09 | No | No | Current |
| 57237-347-05 | 57237034705 | 500 TABLET, FILM COATED in 1 BOTTLE (57237-347-05) | 2025-11-04 | No | No | Current |