NIGHTTIME COLD AND FLU (Acetaminophen, Dextromethorphan HBr, Doxylamine succinate) by Amazon.com Services LLC: new human otc drug listing

NIGHTTIME COLD AND FLU: new human otc drug listing. Dated 42 days ago, it serves as a historical benchmark. Score 15/100. As of 2026-11-04, 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
ProductNIGHTTIME COLD AND FLU
Generic nameAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC72288-322
LabelerAmazon.com Services LLC
Product typeHUMAN OTC DRUG
Approval pathwayOTC MONOGRAPH DRUG
Application numberM012
Dosage formCAPSULE, LIQUID FILLED
RouteORAL
Active ingredientsACETAMINOPHEN 325 mg/1; DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1; DOXYLAMINE SUCCINATE 6.25 mg/1
Marketing start2026-09-24
Package configurations1
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-09-24
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Wed, 04 Nov 2026 18:12:05 GMT

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Peer benchmark and outreach value: NIGHTTIME COLD AND FLU and 2,418 HUMAN OTC DRUG peers

  • HUMAN OTC DRUG FdaNdcDirectoryPulse records like this one: 2,418
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every HUMAN OTC DRUG peer: $483,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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15 / 100 Launch Signal Score

    What is the FdaNdcDirectoryPulse record for NIGHTTIME COLD AND FLU?

    NIGHTTIME COLD AND FLU by Amazon.com Services LLC: new human otc drug listing (OTC MONOGRAPH DRUG) starting 2026-09-24.

    How does NIGHTTIME COLD AND FLU compare to other FdaNdcDirectoryPulse records?

    It is 42 days old, still within a typical 45-day follow-up window. Its Launch Signal Score of 15/100 is modest; treat it as background rather than a priority.

    NIGHTTIME COLD AND FLU vs. top 3 peers

    OrganizationLocationRecord dateCompare
    NIGHTTIME COLD AND FLUHUMAN OTC DRUG2026-09-24This record
    BRYTLYHUMAN OTC DRUG2026-10-16Compare NIGHTTIME COLD AND FLU vs BRYTLY →
    OMEPRAZOLEHUMAN OTC DRUG2026-09-11View record →
    Nicotine Transdermal System step 1HUMAN OTC DRUG2026-09-01View record →

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    FdaNdcDirectoryPulse: Over the counter (OTC) FdaNdcDirectoryPulse: OTC monograph

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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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