Simethicone
- Product NDC
- 35916-1940
- 11-digit product format
- 359161940
- Labeler code
- 35916
- Product ID
- 35916-1940_47de40b6-7551-02cd-e063-6394a90a5b0a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-28
- Substance
- DIMETHICONE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simethicone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 412111 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35916-1940-1 | Simethicone | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | | 3 |
| 35916-1940-2 | Simethicone | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 3 |
| 35916-1940-2 | Simethicone | 5 in 1 CARTON | CAPSULE, LIQUID FILLED | 5 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 35916-1940-1 | 35916194001 | 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1940-1) | | 2025-10-28 | No | No | Current |
| 35916-1940-2 | 35916194002 | 5 BLISTER PACK in 1 CARTON (35916-1940-2) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 5 blister pack | 2025-10-28 | No | No | Current |