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United States · US · US:37808-503_5acd6b6c-44e0-442f-9d00-9f1a5be68c83

Dual Action Complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3780850363
    25 TABLET, CHEWABLE in 1 BOTTLE (37808-503-63)
  • ndc11
    3780850371
    50 TABLET, CHEWABLE in 1 BOTTLE (37808-503-71)

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": {
    "8d9a0c56-ef22-45a6-8b1d-d2b2f3247210": {
      "match": "brand_token",
      "title": "DUAL ACTION BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [MEIJER, INC.]",
      "spl_version": "2",
      "published_date": "2026-03-23"
    }
  },
  "productid": "37808-503_5acd6b6c-44e0-442f-9d00-9f1a5be68c83",
  "productndc": "37808-503",
  "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": "Dual Action Complete",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA077355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "famotidine, calcium carbonate and magnesium hydroxide",
  "start_marketing_date": "20160407",
  "active_numerator_strength": "800; 10; 165"
}

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