Acetaminophen
- Product NDC
- 57237-347
- Requested package NDC
- 57237-347-01
- 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 Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | cfaf9495-e654-4dfc-ba23-d2358c3720c4 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 18ff2df8-ee65-4219-ad93-cf5090bfac2d | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | bfb9af64-3195-44bf-bcf3-6b36b40d3cc7 | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1ac7ed71-5afe-d09c-e063-6294a90a3b88 | 2024-06-13 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 3f73a359-59d7-47bb-872e-914b0db719af | 2024-06-13 | Warnings | M013 |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f1e940ef-3cf0-4a5c-8158-156d0e5a680d | 2024-06-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 7c73fc75-af9b-177c-e053-2a91aa0ada56 | 2024-06-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Topco Associates | 4a6a1dbb-c813-42fd-9bb8-497aec339466 | 2024-06-11 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | fa234639-caf8-4c52-9ffe-f1c0c057ee5b | 2024-06-10 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | bc18590d-6481-4efe-8a3b-974f7543b754 | 2024-06-10 | Warnings | M013 |
| ASPIRIN | ASPIRIN | H-E-B | 085b35db-62e4-38db-e063-6394a90a9763 | 2024-06-07 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | 5691ac45-5732-412e-abb8-2bfaac59160e | 2024-06-07 | Warnings | M013 |
| Cafiaspirina Rapid Headache Relief | ASPIRIN, CAFFEINE | Belmora LLC | d890acec-6528-4fb7-8d59-6c572a3f0786 | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | TARGET Corporation | 611bc1ce-460a-44a3-8e2d-b28a399d9a44 | 2024-06-06 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Meijer Distribution Inc | 033a6153-2651-4703-8a94-def461838113 | 2024-06-05 | 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 |