SIMETHICONE INFANT
- Product NDC
- 17856-1018
- 11-digit product format
- 178561018
- Labeler code
- 17856
- Product ID
- 17856-1018_4d658648-1d31-b0fe-e063-6294a90a0ca6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp.
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-20
- Substance
- DIMETHICONE
- Active strength
- 20 mg/.3mL
- 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 INFANT
- Brand name suffix
- Gas Relief Drops
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 20 mg/.3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 198857 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-1018-1 | SIMETHICONE INFANTGas Relief Drops | 0.3 mL in 1 SYRINGE | SUSPENSION | 0.3 | | 1 |
| 17856-1018-1 | SIMETHICONE INFANTGas Relief Drops | 60 in 1 CASE | SUSPENSION | 60 | | 1 |
| 17856-1018-3 | SIMETHICONE INFANTGas Relief Drops | 60 in 1 CASE | SUSPENSION | 60 | | 1 |
| 17856-1018-3 | SIMETHICONE INFANTGas Relief Drops | 3 mL in 1 SYRINGE | SUSPENSION | 3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-1018-1 | 17856101801 | 60 SYRINGE in 1 CASE (17856-1018-1) / .3 mL in 1 SYRINGE | 60 syringe | 2026-03-16 | No | No | Current |
| 17856-1018-3 | 17856101803 | 60 SYRINGE in 1 CASE (17856-1018-3) / 3 mL in 1 SYRINGE | 60 syringe | 2026-03-16 | No | No | Current |