ACETAMINOPHEN
- Product NDC
- 0615-8398
- Requested package NDC
- 0615-8398-67
- 11-digit product format
- 006158398
- Labeler code
- 0615
- Product ID
- 0615-8398_bee08ab5-e196-44f5-af0c-f94848b9114e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2011-12-15
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 325 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0615-8398 | 0615-8398-67 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8398-67 | ACETAMINOPHEN | 60 in 1 BLISTER PACK | TABLET | 60 | 11 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 3f2eadf9-9bb3-437e-972d-232828ca9d34 | 2024-06-12 | Warnings | 0615-8398-67 0615-8398 00615839867 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 3f2eadf9-9bb3-437e-972d-232828ca9d34 | 11 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 3f2eadf9-9bb3-437e-972d-232828ca9d34 | 11 |
| 313782 | APAP 325 MG Oral Tablet | SY | 3f2eadf9-9bb3-437e-972d-232828ca9d34 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0615-8398-67 | 00615839867 | 60 TABLET in 1 BLISTER PACK (0615-8398-67) | 60 tablet | 2021-04-22 | 0000-00-00 | No | No | Current |