ACETAMINOPHEN
- Product NDC
- 0615-8397
- Requested package NDC
- 0615-8397-39
- 11-digit product format
- 006158397
- Labeler code
- 0615
- Product ID
- 0615-8397_224b3b3d-1dc4-457c-b6a8-6ee82498daf6
- 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
- 2024-12-31
- 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 | 0615-8397 | 0615-8397-39 | D | Discontinued by firm | 2026-11-03 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8397-05 | ACETAMINOPHEN | 15 in 1 BLISTER PACK | TABLET | 15 | 11 | |
| 0615-8397-30 | ACETAMINOPHEN | 5 in 1 BLISTER PACK | TABLET | 5 | 11 | |
| 0615-8397-30 | ACETAMINOPHEN | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | 11 | |
| 0615-8397-39 | ACETAMINOPHEN | 30 in 1 BLISTER PACK | TABLET | 30 | 11 |
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 | bb450552-728a-4675-b0a9-0fd2934f6c5e | 2024-08-19 | Warnings | 0615-8397-39 0615-8397 00615839739 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | bb450552-728a-4675-b0a9-0fd2934f6c5e | 11 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | bb450552-728a-4675-b0a9-0fd2934f6c5e | 11 |
| 313782 | APAP 325 MG Oral Tablet | SY | bb450552-728a-4675-b0a9-0fd2934f6c5e | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0615-8397-39 | 00615839739 | 30 TABLET in 1 BLISTER PACK (0615-8397-39) | 30 tablet | 2021-04-26 | 0000-00-00 | No | No | Current |