Simethicone 125 mg
- Product NDC
- 82804-152
- 11-digit product format
- 828040152
- Labeler code
- 82804
- Product ID
- 82804-152_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
- 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
- 2018-04-25
- Substance
- DIMETHICONE
- Active strength
- 125 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 125 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 314221 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-152-09 | Simethicone 125 mg | 9 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 9 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-152 | SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20241006_078ef54e-96b2-4e2f-bebc-9b9bcda1f90a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-152-09 | 82804015209 | 9 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-152-09) | 2024-09-25 | No | No | Current |