DESENFRIOL-ITO PLUS
- Product NDC
- 69729-815
- 11-digit product format
- 697290815
- Labeler code
- 69729
- Product ID
- 69729-815_5ce4d62e-9a0a-92fd-e063-6394a90ad310
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-15
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- DESENFRIOL-ITO PLUS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-815-04 | 69729081504 | 1 BOTTLE in 1 CARTON (69729-815-04) / 118 mL in 1 BOTTLE | 1 bottle | 2026-06-15 | No | No | Current |