Guaifenesin and Dextromethorphan HBr

Orange BookUNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
5860271405
1 BOTTLE in 1 CARTON (58602-714-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271407
6 BLISTER PACK in 1 CARTON (58602-714-07) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)
ndc11
5860271408
4 BLISTER PACK in 1 CARTON (58602-714-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)
ndc11
5860271409
1 BOTTLE in 1 CARTON (58602-714-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271412
1 BOTTLE in 1 CARTON (58602-714-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271415
1 BOTTLE in 1 CARTON (58602-714-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271466
1 BOTTLE in 1 CARTON (58602-714-66) / 58 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271467
2 BLISTER PACK in 1 CARTON (58602-714-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)
ndc11
5860271473
1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

Orange Book

A206941

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "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": "58602-714_cfc45418-1bd2-4f68-b1c9-ed3f2bc006aa",
  "productndc": "58602-714",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206941",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "002",
        "approval_date": "Mar 17, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Guaifenesin and Dextromethorphan HBr",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA206941",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin and Dextromethorphan HBr",
  "start_marketing_date": "20170317",
  "active_numerator_strength": "30; 600"
}

Related drugs

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