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United States · US · US:76162-123_e0a05c1e-af6d-4d2d-9d0e-80f1821f5266

Topcare mucus er

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7616212358
    1 BOTTLE in 1 CARTON (76162-123-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
  • ndc11
    7616212360
    1 BOTTLE in 1 CARTON (76162-123-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A078912
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "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": "76162-123_e0a05c1e-af6d-4d2d-9d0e-80f1821f5266",
  "productndc": "76162-123",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Nov 5, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Topcare mucus er",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin",
  "start_marketing_date": "20220929",
  "active_numerator_strength": "600"
}

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