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United States · US · US:55910-383_5cec42ac-7fba-4078-9304-90172a851312

dg health anti diarrheal anti gas

Orange BookSPLATC P03AX

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

Identification

ManufacturerDolgencorp, LLC
CountryUS (United States)
ATC codeP03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5591038353
    12 BLISTER PACK in 1 CARTON (55910-383-53) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    5591038362
    24 BLISTER PACK in 1 CARTON (55910-383-62) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    5591038389
    18 BLISTER PACK in 1 CARTON (55910-383-89) / 1 TABLET in 1 BLISTER PACK

Annotations

Orange Book
A209837
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "5f0514bd-7893-4602-a17b-716fb9947572": {
      "match": "brand_token",
      "title": "DG HEALTH ALLERGY RELIEF NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [DOLGENCORP INC]",
      "spl_version": "9",
      "published_date": "2026-02-10"
    }
  },
  "productid": "55910-383_5cec42ac-7fba-4078-9304-90172a851312",
  "productndc": "55910-383",
  "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": "dg health 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": "20181009",
  "active_numerator_strength": "125; 2"
}

Related drugs

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