Infants Gas relief
- Product NDC
- 36800-119
- 11-digit product format
- 368000119
- Labeler code
- 36800
- Product ID
- 36800-119_edbc1a70-0fe7-42c4-a835-140c9f6aaf4a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- SOLUTION/ DROPS
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-03-01
- Substance
- DIMETHICONE
- Active strength
- 20 mg/.3mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Infants Gas relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 20 mg/.3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-119-09 | Infants Gas relief | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | | 2 |
| 36800-119-09 | Infants Gas relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-119 | INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [TOPCO ASSOCIATES, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241228_fd6a2537-8db2-492d-b045-6404df2fb9c3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-119-09 | 36800011909 | 1 BOTTLE, DROPPER in 1 CARTON (36800-119-09) / 30 mL in 1 BOTTLE, DROPPER | 2013-03-01 | 0000-00-00 | No | No | Current |