M-PAP
- Product NDC
- 58657-524
- 11-digit product format
- 586570524
- Labeler code
- 58657
- Product ID
- 58657-524_41b5cace-10a5-04fa-e063-6394a90af9fa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- 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
- M-PAP
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307675 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1539dc44-15a0-153b-e063-6294a90a9d45 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-524-04 | M-PAP | 120 mL in 1 BOTTLE | LIQUID | 120 | 3 | |
| 58657-524-16 | M-PAP | 473 mL in 1 BOTTLE | LIQUID | 473 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-524-04 | ML - Milliliter | 58657-524 | 61cca8ca-d3d3-4387-a446-52a2492aa7bf | 1 | 2024-05-16 |
| 58657-524-16 | ML - Milliliter | 58657-524 | 47a56d48-9746-42a0-82be-38c8e9a6382d | 1 | 2024-05-16 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 100 |
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 1539dc44-15a0-153b-e063-6294a90a9d45 | 3 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | c6cec390-004e-45f6-9388-c662a979f37d | 3 |
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58657-524-04 | 58657052404 | 120 mL in 1 BOTTLE (58657-524-04) | 120 ml | 2024-04-01 | No | No | Current |
| 58657-524-16 | 58657052416 | 473 mL in 1 BOTTLE (58657-524-16) | 473 ml | 2024-04-01 | No | No | Current |