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United States · US · US:65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101

Gelusil

UNIISPLATC P03AX

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

Identification

ManufacturerWellSpring Pharmaceutical Corporation
CountryUS (United States)
ATC codeP03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6519730010
    10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • ndc11
    6519730011
    100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)

Annotations

UNII (FDA Substance ID)
5QB0T2IUN0
ALUMINUM HYDROXIDE
RxCUI 81948
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5QB0T2IUN0",
    "rxcui": "81948",
    "inchikey": "WNROFYMDJYEPJX-UHFFFAOYSA-K",
    "display_name": "ALUMINUM HYDROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "92fbeec1-1562-40f3-9734-41f133d494f9": {
      "match": "brand_token",
      "title": "GELUSIL (ALUMINA, MAGNESIA, SIMETHICONE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]",
      "spl_version": "26",
      "published_date": "2025-11-21"
    }
  },
  "productid": "65197-300_4406bf6b-b261-c6e1-e063-6294a90ae101",
  "productndc": "65197-300",
  "dosage_form": "TABLET, CHEWABLE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ALUMINUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE; SILICON DIOXIDE",
  "proprietary_name": "Gelusil",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M001",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Alumina, Magnesia, Simethicone",
  "start_marketing_date": "20080924",
  "active_numerator_strength": "200; 24; 200; 1"
}

Related drugs

Other records sharing ATC code P03AX.

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