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 |
|---|---|---|---|---|---|---|
| PANADOL Extra | ACETAMINOPHEN AND CAFFEINE | Haleon US Holdings LLC | e5c2d88a-d903-4ca0-b895-f27e791dfc4e | 2024-02-06 | Warnings | M013 |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b | 2024-02-06 | Warnings | M013 |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | 9d384e88-5c11-4600-ac6c-a38371570138 | 2024-02-06 | Warnings | M013 |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | 95801755-db54-4ad7-bec1-52671914f6ca | 2024-02-06 | Warnings | M013 |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 01e7dddb-755c-4745-b701-edcdb6209064 | 2024-02-06 | Warnings, Adverse reactions | M013 |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 9064943f-836f-4853-b6f2-2c4879941eeb | 2024-02-02 | Warnings | M013 |
| Quality Choice Effervescent Pain Relief | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 079af5d7-1be8-2a93-e063-6294a90a496d | 2024-02-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin | ACETAMINOPHEN | Proficient Rx LP | 4c84948d-3a95-4c53-8529-7e7b9d8bb6df | 2024-02-01 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 9c7d65e4-df2f-47c1-a185-66aaf19aad2b | 2024-02-01 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Proficient Rx LP | 57e4820c-b4eb-442e-9c49-93eedfbc5e5e | 2024-02-01 | Warnings | M013 |
| good sense aspirin | ASPIRIN | Proficient Rx LP | 73013074-9c6e-43c7-acde-4d9d8ed0133d | 2024-02-01 | Warnings | M013 |
| MEDIQUE APAP Extra Strength | ACETAMINOPHEN | Proficient Rx LP | c466a07f-2339-4cf5-8377-e0f109649c52 | 2024-02-01 | Warnings | M013 |
| Percogesic Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE | Medtech Products Inc. | 2c5f1140-fb83-42c9-b0b1-5e2bd69340bb | 2024-02-01 | Warnings | M013 |
| aspirin | ASPIRIN | Proficient Rx LP | 3c7783a7-2b28-4968-b766-0a49dc70ce6d | 2024-02-01 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 102bdcde-cb90-f248-e063-6394a90aac79 | 2024-01-30 | Warnings | M013 |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | 61802b27-c9ec-4386-9d44-45e8b1e558b7 | 2024-01-28 | Warnings | M013 |
| AGRIFEN | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | 0fde22da-cdfc-36cc-e063-6294a90a3885 | 2024-01-26 | Warnings | M013 |
| DOLODOL | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | e80536f1-92cc-5bb3-e053-2995a90a9540 | 2024-01-26 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | d913d11f-c7a1-49d2-a2d3-9a29fc032806 | 2024-01-18 | 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 |