Simethicone
- Product NDC
- 53345-009
- 11-digit product format
- 533450009
- Labeler code
- 53345
- Product ID
- 53345-009_2767d80e-d134-20a7-e063-6394a90aab4f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-04-15
- 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
- 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 | 198852 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-009-01 | Simethicone | 25000 in 1 BAG | CAPSULE, LIQUID FILLED | 25000 | | 3 |
| 53345-009-01 | Simethicone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-009 | SIMETHICONE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241122_0f9639fa-e1d0-460d-bc46-714a01cd9811.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 |
|---|
| 53345-009-01 | 53345000901 | 1 BAG in 1 BOX (53345-009-01) / 25000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-04-15 | 0000-00-00 | No | No | Current |