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United States · US · US:53329-014_27d44bbd-bd6d-844e-e063-6394a90a6273

Pure and Gentle Laxative

In shortageSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMedline Industries, LP
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5332901411
    1 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE
  • ndc11
    5332901458
    24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE

Annotations

DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Acetate Injection
Raw payload (JSON)
{
  "route": "RECTAL",
  "spl_meta": {
    "52efd466-49bd-bbdf-e063-6394a90aa108": {
      "match": "brand_token",
      "title": "PURE PETROLATUM (PETROLATUM) JELLY [VASA COSMETICS PRIVATE LIMITED]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "53329-014_27d44bbd-bd6d-844e-e063-6394a90a6273",
  "productndc": "53329-014",
  "dosage_form": "ENEMA",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
  "shortage_reason": "Sodium Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Pure and Gentle Laxative",
  "active_ingred_unit": "g/118mL; g/118mL",
  "application_number": "M007",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "sodium phosphate",
  "start_marketing_date": "20140409",
  "active_numerator_strength": "7; 19"
}

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