Anti-Diarrheal
- Product NDC
- 41520-520
- 11-digit product format
- 415200520
- Labeler code
- 41520
- Product ID
- 41520-520_358c89ad-4c0b-4288-b729-088840a0d3fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Care One (American Sales Company)
- Application
- NDA021855
- Marketing category
- NDA
- Marketing start
- 2010-08-05
- Marketing end
- 2025-05-30
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| GLYCERYL CAPRYLATE | INACTIVE INGREDIENT | TM2TZD4G4A | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-520 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] | 7 | Legacy NDC | 20221122_057c724e-f03e-4120-8cd1-ae58104e1c21.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41520-520-12 | 41520052012 | 1 BLISTER PACK in 1 CARTON (41520-520-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2010-08-05 | 2025-05-30 | No | No | Current |