# loperamide hydrochloride and simethicone (loperamide hydrochloride, simethicone) by Amazon.com Services LLC: new human otc drug listing

**Launch Signal Score:** 40/100

| Field | Value |
|---|---|
| Product | loperamide hydrochloride and simethicone |
| Generic name | loperamide hydrochloride, simethicone |
| NDC | 72288-728 |
| Labeler | Amazon.com Services LLC |
| Product type | HUMAN OTC DRUG |
| Approval pathway | ANDA |
| Application number | ANDA209837 |
| Dosage form | TABLET |
| Route | ORAL |
| Active ingredients | LOPERAMIDE HYDROCHLORIDE 2 mg/1; DIMETHICONE 125 mg/1 |
| Marketing start | 2026-09-24 |
| Package configurations | 1 |

## Why this score
- New generic entry: wholesalers and GPOs re-bid contracts.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=72288-728). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.