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United States · US · US:0113-7050_b5a36da3-7316-493c-b50f-fc5393d858c0

GOOD SENSE DUAL ACTION COMPLETE

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0113705071
    50 TABLET, CHEWABLE in 1 BOTTLE (0113-7050-71)

Annotations

UNII (FDA Substance ID)
H0G9379FGK
CALCIUM CARBONATE
RxCUI 1897
Orange Book
A077355
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "H0G9379FGK",
    "rxcui": "1897",
    "inchikey": "VTYYLEPIZMXCLO-UHFFFAOYSA-L",
    "display_name": "CALCIUM CARBONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "0113-7050_b5a36da3-7316-493c-b50f-fc5393d858c0",
  "productndc": "0113-7050",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "077355",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "800MG;10MG;165MG",
        "product_no": "001",
        "approval_date": "Feb 6, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "GOOD SENSE DUAL ACTION COMPLETE",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA077355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "famotidine, calcium carbonate, magnesium hydroxide",
  "start_marketing_date": "20251120",
  "active_numerator_strength": "800; 10; 165"
}

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