loperamide hydrochloride and simethicone (loperamide hydrochloride, simethicone) by Amazon.com Services LLC: new human otc drug listing
loperamide hydrochloride and simethicone: new human otc drug listing. Dated 41 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-03, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 12 published fields of this record are shown below. Locked: 499 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| 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 |
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- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-09-24
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Tue, 03 Nov 2026 18:09:00 GMT
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Peer benchmark and outreach value: loperamide hydrochloride and simethicone and 2,323 HUMAN OTC DRUG peers
- HUMAN OTC DRUG FdaNdcDirectoryPulse records like this one: 2,323
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HUMAN OTC DRUG peer: $464,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
40 / 100 Launch Signal Score
- New generic entry: wholesalers and GPOs re-bid contracts.
What is the FdaNdcDirectoryPulse record for loperamide hydrochloride and simethicone?
loperamide hydrochloride and simethicone by Amazon.com Services LLC: new human otc drug listing (ANDA) starting 2026-09-24.
How does loperamide hydrochloride and simethicone compare to other FdaNdcDirectoryPulse records?
It is 41 days old, still within a typical 45-day follow-up window.
loperamide hydrochloride and simethicone vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| loperamide hydrochloride and simethicone | HUMAN OTC DRUG | 2026-09-24 | This record |
| BRYTLY | HUMAN OTC DRUG | 2026-10-16 | Compare loperamide hydrochloride and simethicone vs BRYTLY → |
| OMEPRAZOLE | HUMAN OTC DRUG | 2026-09-11 | View record → |
| Nicotine Transdermal System step 1 | HUMAN OTC DRUG | 2026-09-01 | View record → |
Related records
FdaNdcDirectoryPulse: Over the counter (OTC) FdaNdcDirectoryPulse: Generic (ANDA)
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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.