SIMETHICONE 80MG
- Product NDC
- 77333-812
- 11-digit product format
- 773330812
- Labeler code
- 77333
- Product ID
- 77333-812_0e765edc-264e-533a-e063-6394a90a7c53
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SIMETHICONE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Gendose Pharmaceuticals, LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-02
- 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 80MG
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77333-812-10 | SIMETHICONE 80MG | 100 in 1 BOX | TABLET, CHEWABLE | 100 | | 6 |
| 77333-812-25 | SIMETHICONE 80MG | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77333-812 | SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [GENDOSE PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240504_e7f470cf-f036-afd9-e053-2995a90a9186.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 77333-812-10 | 77333081210 | 100 BLISTER PACK in 1 BOX (77333-812-10) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25) | 100 blister pack | 2022-10-15 | 0000-00-00 | No | No | Current |
| 77333-812-25 | 77333081225 | 1 in 1 BLISTER PACK | | | | | | Historical |