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United States · US · US:0113-0087_7fbd19ec-7b82-4f11-95f0-28801a9c64b4

good sense anti diarrheal anti gas

Orange BookSPLATC P03AX

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeP03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0113008753
    12 BLISTER PACK in 1 CARTON (0113-0087-53) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    0113008762
    24 BLISTER PACK in 1 CARTON (0113-0087-62) / 1 TABLET in 1 BLISTER PACK

Annotations

Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0113-0087_7fbd19ec-7b82-4f11-95f0-28801a9c64b4",
  "productndc": "0113-0087",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209837",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG;125MG",
        "product_no": "001",
        "approval_date": "Sep 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "good sense anti diarrheal anti gas",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209837",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loperamide hydrochloride, simethicone",
  "start_marketing_date": "20181011",
  "active_numerator_strength": "125; 2"
}

Related drugs

Other records sharing ATC code P03AX.

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