SODIUM PHENYLACETATE and SODIUM BENZOATE

In shortageOrange BookUNIISPL

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

Identification

ManufacturerOmnivium Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8166520301
1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

OJ245FE5EU

SODIUM BENZOATE

RxCUI 56455

Orange Book

A207096

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "OJ245FE5EU",
    "rxcui": "56455",
    "inchikey": "WXMKPNITSTVMEF-UHFFFAOYSA-M",
    "display_name": "SODIUM BENZOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52430b12-4d5f-d1e1-e063-6394a90abd64": {
      "match": "brand_token",
      "title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "81665-203_ab598188-342a-419e-9471-a7b60a25b198",
  "productndc": "81665-203",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "207096",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "10%;10% (5GM/50ML;5GM/50ML)",
        "product_no": "001",
        "approval_date": "Feb 24, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "SODIUM PHENYLACETATE and SODIUM BENZOATE",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA207096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium phenylacetate and sodium benzoate",
  "start_marketing_date": "20250225",
  "active_numerator_strength": "100; 100"
}

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