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United States · US · US:42681-0057_7c890031-8188-48be-bb69-06db0e01a0c0

365 WHOLE FOODS MARKET GUAIFENESIN

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerWhole Foods Market, Inc.
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4268100571
    1 BOTTLE in 1 CARTON (42681-0057-1) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A210453
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": {
    "25bc7ab1-116d-143a-e063-6394a90aa970": {
      "match": "brand_token",
      "title": "365 WHOLE FOODS MARKET SPEARMINT FLAVORED FLUORIDE MOUTHWASH ANTICAVITY (FLUORIDE) MOUTHWASH [WHOLE FOODS]",
      "spl_version": "3",
      "published_date": "2026-05-14"
    }
  },
  "productid": "42681-0057_7c890031-8188-48be-bb69-06db0e01a0c0",
  "productndc": "42681-0057",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210453",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Oct 21, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Oct 21, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "365 WHOLE FOODS MARKET GUAIFENESIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210453",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20260123",
  "active_numerator_strength": "600"
}

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