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 |
|---|---|---|---|---|---|---|
| pain relief childrens | ACETAMINOPHEN | Rite Aid Corporation | 29ecdd2d-aeaf-40a8-a347-011088009ea6 | 2026-08-11 | Warnings | M013 |
| Fast Acting Pedia Crae | ACETAMINOPHEN | Randob Labs., Ltd. | e069060f-fbb2-4c7a-b872-00b3ab86d01b | 2026-08-11 | Warnings | M013 |
| ASPIRIN | ASPIRIN | Amazon.com Services LLC | c7cc0681-4c0b-4565-99df-d0168c8ba1ba | 2026-08-10 | Warnings | M013 |
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 | 2026-08-09 | Warnings | M013 |
| Gencare-Aspirin Low Dose Pain reliever (NSAID) | ASPIRIN | Pioneer Life Sciences, LLC | 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc | 2026-08-09 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | DOLGENCORP, LLC | b4064039-2345-4227-b83d-54dc13a838d3 | 2026-08-07 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 87def9e0-0246-42cf-b8ea-2513d52e9f68 | 2026-08-07 | Warnings | M013 |
| berkley and jensen acetaminophen | ACETAMINOPHEN | BJWC | dee57d73-73ac-48bb-b1da-9971f1ff21c4 | 2026-08-07 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Salado Sales, Inc. | aef30709-f33d-48ff-b2d4-0639ffbd1ffd | 2026-08-07 | Warnings | M013 |
| Aspirin | ASPIRIN | P & L Development, LLC | 4cd74cec-a209-4e92-b853-fbe5c95f7678 | 2026-08-06 | Warnings | M013 |
| Tension Headache Aspirin-Free | ACETAMINOPHEN, CAFFEINE | Rite Aid Corporation | 093a7c26-f2b1-4416-b193-81133d247d2e | 2026-08-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Kroger Company | bc17b2e5-4828-6a2e-e053-2995a90a8c63 | 2026-08-05 | Warnings | M013 |
| Infants TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 997b9551-c222-4a9c-8ba1-09a5f97495fa | 2026-08-05 | Warnings | M013 |
| Mantra Pain Gel raspberry | ACETAMINOPHEN | MOREMED INC. | 7c8bdf49-a6d2-4e42-b006-375f103fd0ac | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | d2d2846d-4e0b-4d42-b300-60dd3b2cca1b | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | 960f5676-d8c5-470b-a663-4b8d152339b4 | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | a60f6439-2033-4bd2-b78c-6c083414a12b | 2026-08-05 | Warnings | M013 |
| pain relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HARRIS TEETER | 0afb6181-d0b1-4845-8230-faabf1b997dc | 2026-08-05 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 8a3e3439-90ae-4fc9-8ff2-44b8363fa338 | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Harris Teeter | 50e7b939-e0eb-44ea-82ea-034e844e2c29 | 2026-08-05 | 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 |