Sodium Phenylacetate and Sodium Benzoate

In shortageOrange BookUNIISPL

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

Identification

ManufacturerMAIA PHARMACEUTICALS

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051110220
1 VIAL, SINGLE-DOSE in 1 CARTON (70511-102-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

OJ245FE5EU

SODIUM BENZOATE

RxCUI 56455

Orange Book

N215025

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Oxybate Solution

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": "70511-102_b14a3aa1-8456-404a-8afd-85d7ca272ab1",
  "productndc": "70511-102",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215025",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10%;10% (2GM/20ML;2GM/20ML)",
        "product_no": "001",
        "approval_date": "Jun 10, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "Sodium Phenylacetate and Sodium Benzoate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA215025",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Phenylacetate and Sodium Benzoate",
  "start_marketing_date": "20210701",
  "active_numerator_strength": "100; 100"
}

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