Simethicone
- Product NDC
- 48769-113
- 11-digit product format
- 487690113
- Labeler code
- 48769
- Product ID
- 48769-113_7871e699-2df2-4655-b2db-a2b721d145ac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Softech Pharma Pvt. Ltd
- Application
- part332
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2012-01-15
- Marketing end
- 0000-00-00
- Substance
- DIMETHICONE
- Active strength
- 125 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48769-113-99 | Simethicone | 5000 in 1 BAG | CAPSULE, LIQUID FILLED | 5000 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dimethicone | ACTIVE INGREDIENT | 92RU3N3Y1O | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| Dimethicone | ACTIVE MOIETY | 92RU3N3Y1O | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 48769-113 | SIMETHICONE (DIMETHICONE) CAPSULE, LIQUID FILLED [SOFTECH PHARMA PVT. LTD] | 2 | Legacy NDC, 1 package rows | 20120630_f7ab5814-f48c-4f35-99e1-3db96316351f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 48769-113-99 | 48769011399 | 5000 in 1 BAG | Historical |