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United States · US · US:80267-002_5855b61a-c880-47b0-a67e-4e6cecb47f2c

Betr chest congestion relief

Orange BookUNIISPLATC R05CA03

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

Identification

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

Packs · 1

  • ndc11
    8026700274
    1 BLISTER PACK in 1 CARTON (80267-002-74) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
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": {
    "8c2d5514-62c1-4e98-8412-20534365b934": {
      "match": "brand_token",
      "title": "BETR SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIVE BETR LLC]",
      "spl_version": "4",
      "published_date": "2024-07-24"
    }
  },
  "productid": "80267-002_5855b61a-c880-47b0-a67e-4e6cecb47f2c",
  "productndc": "80267-002",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213420",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Betr chest congestion relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213420",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20210930",
  "active_numerator_strength": "1200"
}

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