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United States · US · US:30142-137_bd1d5672-dce6-47dc-96be-26bce0db708d

Guaifenesin and Pseudoephedrine HCl

Orange BookUNIISPLATC R05CA

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

Identification

ManufacturerKROGER COMPANY
CountryUS (United States)
ATC codeR05CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3014213712
    1 BLISTER PACK in 1 CARTON (30142-137-12) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    3014213717
    2 BLISTER PACK in 1 CARTON (30142-137-17) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213203
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": {
    "9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
      "match": "brand_token",
      "title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
      "spl_version": "8",
      "published_date": "2026-05-21"
    }
  },
  "productid": "30142-137_bd1d5672-dce6-47dc-96be-26bce0db708d",
  "productndc": "30142-137",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213203",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG;60MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM;120MG",
        "product_no": "002",
        "approval_date": "Mar 25, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "Guaifenesin and Pseudoephedrine HCl",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA213203",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin and Pseudoephedrine HCl",
  "start_marketing_date": "20210416",
  "active_numerator_strength": "600; 60"
}

Related drugs

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