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United States · US · US:0113-2023_e4f2d30b-3b0f-47e2-bbe1-266297d5de41

good sense mucus er

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0113202358
    1 BOTTLE in 1 CARTON (0113-2023-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
  • ndc11
    0113202360
    1 BOTTLE in 1 CARTON (0113-2023-60) / 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": {
    "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": "0113-2023_e4f2d30b-3b0f-47e2-bbe1-266297d5de41",
  "productndc": "0113-2023",
  "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": "good sense mucus er",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "guaifenesin",
  "start_marketing_date": "20200704",
  "active_numerator_strength": "600"
}

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