ALA-HIST IR

UNIISPLATC R06AB56

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPoly Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR06AB56

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5099178302
12 BLISTER PACK in 1 CARTON (50991-783-02) / 1 TABLET in 1 BLISTER PACK
ndc11
5099178360
60 TABLET in 1 BOTTLE, PLASTIC (50991-783-60)

Annotations

UNII (FDA Substance ID)

BPA9UT29BS

DEXBROMPHENIRAMINE MALEATE

RxCUI 48936

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BPA9UT29BS",
    "rxcui": "48936",
    "inchikey": "SRGKFVAASLQVBO-DASCVMRKSA-N",
    "display_name": "DEXBROMPHENIRAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0d203b5c-8b10-428b-8703-17be6b4ce6eb": {
      "match": "brand_token",
      "title": "ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]",
      "spl_version": "11",
      "published_date": "2025-12-09"
    }
  },
  "productid": "50991-783_4513db4f-e8f2-ecc6-e063-6294a90a1b17",
  "productndc": "50991-783",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXBROMPHENIRAMINE MALEATE",
  "proprietary_name": "ALA-HIST IR",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Dexbrompheniramine Maleate",
  "start_marketing_date": "20110822",
  "active_numerator_strength": "2"
}

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