Loperamide Hydrochloride and Simethicone
- Product NDC
- 55319-052
- 11-digit product format
- 553190052
- Labeler code
- 55319
- Product ID
- 55319-052_dfa3e363-cb7c-4f7a-9404-04f70312ab53
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride and Simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Family Dollar Stores, LLC
- Application
- ANDA211059
- Marketing category
- ANDA
- Marketing start
- 2023-08-11
- 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 |
|---|
| 55319-052-75 | Loperamide Hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
| 55319-052-75 | Loperamide Hydrochloride and Simethicone | 2 in 1 CARTON | TABLET | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-052 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [FAMILY DOLLAR STORES, LLC] | 3 | Current NDC, 2 package rows | 20250112_f86d2c23-c43a-4190-e053-6394a90a95cc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-052-75 | 55319005275 | 2 BLISTER PACK in 1 CARTON (55319-052-75) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-08-11 | No | No | Historical |