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United States · US · US:82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c

SIMETHICONE INFANT

SPLATC P03AX05

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

Identification

ManufacturerAARNA USA Inc.
CountryUS (United States)
ATC codeP03AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8256800173
    1 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE
  • ndc11
    8256800174
    118 mL in 1 BOTTLE (82568-0017-4)

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": "82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c",
  "productndc": "82568-0017",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE",
  "proprietary_name": "SIMETHICONE INFANT",
  "active_ingred_unit": "mg/.3mL",
  "application_number": "M002",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Simethicone",
  "start_marketing_date": "20250220",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code P03AX05.

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