Simethicone
- Product NDC
- 53345-036
- 11-digit product format
- 533450036
- Labeler code
- 53345
- Product ID
- 53345-036_27c818a0-ee73-b3e3-e063-6394a90a83e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-25
- Substance
- DIMETHICONE
- Active strength
- 180 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 | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O |
| Rxcui | 252294 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-036-01 | Simethicone | 25000 in 1 BAG | CAPSULE, LIQUID FILLED | 25000 | | 2 |
| 53345-036-01 | Simethicone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-036 | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241127_346df37d-b0fc-4fa5-8c19-492fed58c239.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 |
|---|
| 53345-036-01 | 53345003601 | 1 BAG in 1 BOX (53345-036-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2016-07-25 | 0000-00-00 | No | No | Current |