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United States · US · US:57631-018_4024f888-60d7-f820-e063-6394a90ab81d

Phenylephrine Hydrochloride

UNIISPLATC R01AA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerInvaTech Pharma Solutions LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5763101800
    30000 TABLET in 1 DRUM (57631-018-00)

Annotations

UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "04JA59TNSJ",
    "rxcui": "8164",
    "inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
    "display_name": "PHENYLEPHRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d92631a6-bae8-493b-b4df-c563346607a8": {
      "match": "brand_token",
      "title": "PHENYLEPHRINE HYDROCHLORIDE INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-20"
    }
  },
  "productid": "57631-018_4024f888-60d7-f820-e063-6394a90ab81d",
  "productndc": "57631-018",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Phenylephrine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine Hydrochloride",
  "start_marketing_date": "20210113",
  "active_numerator_strength": "10"
}

Related drugs

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