Promethazine Hydrochloride and Phenylephrine Hydrochloride

{
  "unii": {
    "unii": "04JA59TNSJ",
    "rxcui": "8164",
    "inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
    "display_name": "PHENYLEPHRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d": {
      "match": "brand_token",
      "title": "PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "19",
      "published_date": "2026-05-25"
    }
  },
  "productid": "65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334a",
  "productndc": "65162-679",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG/5ML;6.25MG/5ML",
        "product_no": "001",
        "approval_date": "Aug 25, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
  "proprietary_name": "Promethazine Hydrochloride and Phenylephrine Hydrochloride",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "ANDA040902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Promethazine and Phenylephrine",
  "start_marketing_date": "20090825",
  "active_numerator_strength": "5; 6.25"
}