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United States · US · US:36800-082_8ff82275-ff8b-4073-ab1d-5f802e0c21a4

topcare dual action complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3680008263
    25 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63)

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": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-082_8ff82275-ff8b-4073-ab1d-5f802e0c21a4",
  "productndc": "36800-082",
  "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": "topcare 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": "20160229",
  "active_numerator_strength": "800; 10; 165"
}

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