Simethicone 125 mg
- Product NDC
- 85766-302
- 11-digit product format
- 857660302
- Labeler code
- 85766
- Product ID
- 85766-302_5d433805-c22b-bb28-e063-6294a90a826a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-04-25
- Substance
- DIMETHICONE
- Active strength
- 125 mg/1
- Pharmacologic classes
- Skin Barrier Activity [PE]
- 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
- Simethicone 125 mg
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 125 mg/1 |
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 | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-302-30 | 85766030230 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-30) | 2026-10-07 | No | No | Current |
| 85766-302-60 | 85766030260 | 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-60) | 2026-10-07 | No | No | Current |
| 85766-302-90 | 85766030290 | 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (85766-302-90) | 2026-10-07 | No | No | Current |