SIMETHICONE
- Product NDC
- 71610-649
- 11-digit product format
- 716100649
- Labeler code
- 71610
- Product ID
- 71610-649_2b5afc84-182d-07ef-e063-6294a90a9f3e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2004-01-01
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-649-04 | SIMETHICONE | 4 in 1 BOTTLE | TABLET, CHEWABLE | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-649 | SIMETHICONE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250112_5df94be7-0bc9-4be1-9982-8193e3a3c8ef.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 |
|---|
| 71610-649-04 | 71610064904 | 4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04) | 2022-05-19 | 0000-00-00 | No | No | Current |