Simethicone 80 mg
- Product NDC
- 82804-043
- 11-digit product format
- 828040043
- Labeler code
- 82804
- Product ID
- 82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-04-24
- 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 80 mg
- 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 |
|---|
| 82804-043-30 | Simethicone 80 mg | 30 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 30 | | 2 |
| 82804-043-60 | Simethicone 80 mg | 60 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 60 | | 2 |
| 82804-043-90 | Simethicone 80 mg | 90 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-043 | SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] | 2 | Current NDC, 3 package rows | 20241024_a5e523b3-475e-4d28-a89c-c4325c59c939.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-043-30 | 82804004330 | 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30) | 2023-11-16 | No | No | Current |
| 82804-043-60 | 82804004360 | 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60) | 2023-11-16 | No | No | Current |
| 82804-043-90 | 82804004390 | 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90) | 2023-11-16 | No | No | Current |