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United States · US · US:82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b

Simethicone 80 mg

SPLATC P03AX05

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeP03AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8280404330
    30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-30)
  • ndc11
    8280404360
    60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-60)
  • ndc11
    8280404390
    90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (82804-043-90)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "32018302-7ce5-1f15-e063-6394a90ad378": {
      "match": "brand_token",
      "title": "SIMETHICONE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
      "spl_version": "4",
      "published_date": "2026-04-28"
    }
  },
  "productid": "82804-043_c27c3d6a-64ca-47d4-bba6-a0c5288e755b",
  "productndc": "82804-043",
  "dosage_form": "TABLET, CHEWABLE",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE",
  "proprietary_name": "Simethicone 80 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "M002",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Simethicone",
  "start_marketing_date": "20180424",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code P03AX05.

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