SIMETHICONE
- Product NDC
- 57896-791
- 11-digit product format
- 578960791
- Labeler code
- 57896
- Product ID
- 57896-791_43d043e1-1f90-dc96-e063-6294a90addfb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceuticals, Corp
- 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 |
|---|
| 57896-791-01 | SIMETHICONE | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 7 |
| 57896-791-08 | SIMETHICONE | 80 in 1 BOTTLE | TABLET, CHEWABLE | 80 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
| TRICALCIUM PHOSPHATE | INACTIVE INGREDIENT | K4C08XP666 | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57896-791 | SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241204_be96ce05-dd74-4915-9a8f-2a1b34e2f158.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 |
|---|
| 57896-791-01 | 57896079101 | 100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01) | 2016-09-01 | 0000-00-00 | No | No | Current |
| 57896-791-08 | 57896079108 | 80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08) | 2021-08-01 | 0000-00-00 | No | No | Current |