Loperamide Hydrochloride and Simethicone
- Product NDC
- 58602-869
- 11-digit product format
- 586020869
- Labeler code
- 58602
- Product ID
- 58602-869_32e30a2b-c658-49da-a9ff-e94279e7f8d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride and Simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA211059
- Marketing category
- ANDA
- Marketing start
- 2021-02-24
- Substance
- DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
- Active strength
- 125; 2 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA], 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
- Loperamide Hydrochloride and Simethicone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 125 mg/1 |
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 77TI35393C |
| Rxcui | 978001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-869-76 | Loperamide Hydrochloride and Simethicone | 4 in 1 CARTON | TABLET | 4 | | 5 |
| 58602-869-76 | Loperamide Hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 5 |
| 58602-869-80 | Loperamide Hydrochloride and Simethicone | 3 in 1 CARTON | TABLET | 3 | | 5 |
| 58602-869-80 | Loperamide Hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-869 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [AUROHEALTH LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250112_769e3cc0-6be9-4ab6-88e1-08803d698ef7.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 |
|---|
| 58602-869-76 | 58602086976 | 4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2021-02-24 | 0000-00-00 | No | No | Current |
| 58602-869-80 | 58602086980 | 3 BLISTER PACK in 1 CARTON (58602-869-80) / 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2021-05-16 | 0000-00-00 | No | No | Current |