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United States · US · US:36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088

PE Sinus Congestion

UNIISPLATC R01AA04

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

Identification

ManufacturerTopco Associates, LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3680070407
    2 BLISTER PACK in 1 CARTON (36800-704-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3680070429
    1 BOTTLE, PLASTIC in 1 CARTON (36800-704-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    3680070444
    1 BLISTER PACK in 1 CARTON (36800-704-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK

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": {
    "3264e291-7a0f-4e25-8390-ba441f22f650": {
      "match": "brand_token",
      "title": "PE SINUS CONGESTION (PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]",
      "spl_version": "6",
      "published_date": "2026-01-14"
    }
  },
  "productid": "36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088",
  "productndc": "36800-704",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "PE Sinus Congestion",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine HCl",
  "start_marketing_date": "20220315",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R01AA04.

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