Phenylephrine Hydrochloride

Orange BookUNIISPLATC R01AA04

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

Identification

ManufacturerBausch & Lomb Americas Inc.

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8226010305
1 BOTTLE, DROPPER in 1 CARTON (82260-103-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

N203510

ATAT

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": "OPHTHALMIC",
  "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": "82260-103_278d0147-c5b0-4d85-80f5-500ec567feed",
  "productndc": "82260-103",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "203510",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "2.5%",
        "product_no": "001",
        "approval_date": "Mar 21, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "10%",
        "product_no": "002",
        "approval_date": "Mar 21, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Phenylephrine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA203510",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "phenylephrine hydrochloride",
  "start_marketing_date": "20230331",
  "active_numerator_strength": "25"
}

Related drugs

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