Simethicone
- Product NDC
- 54738-518
- 11-digit product format
- 547380518
- Labeler code
- 54738
- Product ID
- 54738-518_5cc86981-732a-038f-e053-2991aa0a19d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Richmond Pharmaceuticals, Inc.
- Application
- part332
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-03-01
- Substance
- DIMETHICONE
- Active strength
- 80 mg/1
- 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
- Simethicone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 314216 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54738-518-01 | Simethicone | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54738-518 | SIMETHICONE TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20171030_f4be1c0d-01fc-4681-9068-905ed3184534.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54738-518-01 | 54738051801 | 100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01) | 2011-03-01 | 0000-00-00 | No | No | Current |