Simethicone 80 mg
- Product NDC
- 69618-033
- 11-digit product format
- 696180033
- Labeler code
- 69618
- Product ID
- 69618-033_2bc83c5b-6b22-871b-e063-6294a90adbc4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Reliable 1 Laboratories LLC
- 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69618-033-01 | Simethicone 80 mg | 100 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69618-033 | SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250117_32fb242b-7051-072c-e054-00144ff88e88.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 |
|---|
| 69618-033-01 | 69618003301 | 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-033-01) | 2018-04-24 | 0000-00-00 | No | No | Current |