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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | 318cc982-23a9-4804-b6fb-248f772d7a38 | 2026-04-02 | Warnings | M013 |
| Chewable Acetaminophen Childrens | ACETAMINOPHEN | Cardinal Health 110, LLC. DBA Leader | 8a18565c-b84e-43f8-8e96-e1dbcc39f08b | 2026-04-02 | Warnings | M013 |
| Childrens Pain Reliever | ACETAMINOPHEN | H E B | c713556c-cb9e-4ed2-bc2f-49b3d6256c0f | 2026-04-02 | Warnings | M013 |
| Aspirin | ASPIRIN | Discount Drug Mart | 4a1e9c79-5036-4c69-82f9-e48abc972b47 | 2026-04-02 | Warnings | M013 |
| Wispirin | ASPIRIN | Wisdrug AG | 4e70ec5e-d033-a525-e063-6394a90a5a93 | 2026-04-01 | Warnings | M013 |
| Aspirin Regimen | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | ef2d75ee-9ed7-4b53-adbc-2ec40364da63 | 2026-03-31 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Hi-Tech Nutraceuticals, LLC | b119ba37-0ee3-851a-e053-2995a90a85b1 | 2026-03-31 | Warnings | M013 |
| Aspirin | ASPIRIN | RMT HEALTH LLC | 4dc7229d-c895-1f80-e063-6394a90abfc3 | 2026-03-30 | Warnings | M013 |
| Aspirin | ASPIRIN | PD-Rx Pharmaceuticals, Inc. | d1f05e56-c830-4f85-b685-2a5965d10a1c | 2026-03-26 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | ad01aea6-4af3-469b-b99d-e1e66aa40e8d | 2026-03-25 | Warnings | M013 |
| aspirin | ASPIRIN | Meijer Distribution Inc | c550b92e-de54-4599-9534-bd3022b0a86d | 2026-03-25 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | db187226-0770-4934-90a4-c6ca50bdecef | 2026-03-25 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 804d4b63-1bbe-47c0-ad49-39ddbeade6a3 | 2026-03-25 | Warnings | M013 |
| childrens pain and fever | ACETAMINOPHEN | HyVee Inc | 9d9c2bf6-8660-4987-8794-936d3102da8d | 2026-03-24 | Warnings | M013 |
| Childrens Pain Reliever | ACETAMINOPHEN | BJWC (Berkley & Jensen / BJ's) | 851228ea-eaf3-452b-a9ce-8cd244a0eaf3 | 2026-03-24 | Warnings | M013 |
| FirstCare Childrens Pain Fever Acetaminophen | ACETAMINOPHEN 80 MG | USpharma Ltd | 9fc05ba6-5667-457e-82c1-a8b4e16cadda | 2026-03-23 | Warnings | M013 |
| Aspirin | ASPIRIN | Aarkish Pharmaceuticals NJ Inc. | e5e9e1ce-666a-461f-8287-a4642902067c | 2026-03-23 | Warnings | M013 |
| Chewable Aspirin Low Dose | CHEWABLE ASPIRIN | Grocery Outlet | 609c0389-8bed-4483-84fa-73ee73fdb4e4 | 2026-03-20 | Warnings | M013 |
| Adult Low Dose Pain Reliever | ASPIRIN | TWIN MED LLC | a395acf4-f487-4c98-8c44-ca2aaaf72deb | 2026-03-20 | Warnings | M013 |
| Rapidol | ACETAMINOPHEN | Pharmadel LLC | 3a210860-1fc1-e496-e063-6394a90a8705 | 2026-03-20 | 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 |