Guaifenesin and Dextromethorphan HBr by INNOVUS PHARMACEUTICALS, INC.: new human otc drug listing

Guaifenesin and Dextromethorphan HBr: new human otc drug listing. Dated 8 days ago, it is in the active follow-up window. 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

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FieldValue
ProductGuaifenesin and Dextromethorphan HBr
Generic nameGuaifenesin and Dextromethorphan HBr
NDC57483-114
LabelerINNOVUS PHARMACEUTICALS, INC.
Product typeHUMAN OTC DRUG
Approval pathwayANDA
Application numberANDA206941
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
Active ingredientsGUAIFENESIN 1200 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1
Marketing start2026-10-27
Package configurations1
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-10-27
  • Data refreshed: 2026-11-03
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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: Guaifenesin and Dextromethorphan HBr and 2,323 HUMAN OTC DRUG peers

  • HUMAN OTC DRUG FdaNdcDirectoryPulse records like this one: 2,323
  • Timing: Medium: dated in the last 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)

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40 / 100 Launch Signal Score

  • New generic entry: wholesalers and GPOs re-bid contracts.

What is the FdaNdcDirectoryPulse record for Guaifenesin and Dextromethorphan HBr?

Guaifenesin and Dextromethorphan HBr by INNOVUS PHARMACEUTICALS, INC.: new human otc drug listing (ANDA) starting 2026-10-27.

How does Guaifenesin and Dextromethorphan HBr compare to other FdaNdcDirectoryPulse records?

It is fresh: dated 8 days ago, inside the window where early outreach matters most.

Guaifenesin and Dextromethorphan HBr vs. top 3 peers

OrganizationLocationRecord dateCompare
Guaifenesin and Dextromethorphan HBrHUMAN OTC DRUG2026-10-27This record
BRYTLYHUMAN OTC DRUG2026-10-16Compare Guaifenesin and Dextromethorphan HBr vs BRYTLY →
OMEPRAZOLEHUMAN OTC DRUG2026-09-11View record →
Nicotine Transdermal System step 1HUMAN OTC DRUG2026-09-01View record →

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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.

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