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 · 12

ndc11
5860271505
1 BOTTLE in 1 CARTON (58602-715-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271506
6 BLISTER PACK in 1 CARTON (58602-715-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
5860271509
1 BOTTLE in 1 CARTON (58602-715-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271510
6 BLISTER PACK in 1 CARTON (58602-715-10) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
5860271515
1 BOTTLE in 1 CARTON (58602-715-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271557
1 BOTTLE in 1 CARTON (58602-715-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271560
1 BOTTLE in 1 CARTON (58602-715-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271564
1 BLISTER PACK in 1 CARTON (58602-715-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
5860271565
2 BLISTER PACK in 1 CARTON (58602-715-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
5860271568
1 BOTTLE in 1 CARTON (58602-715-68) / 38 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271569
1 BOTTLE in 1 CARTON (58602-715-69) / 44 TABLET, EXTENDED RELEASE in 1 BOTTLE
ndc11
5860271570
4 BLISTER PACK in 1 CARTON (58602-715-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "58602-715_8102c39b-c419-433f-9946-7ef777d7c3ef",
  "productndc": "58602-715",
  "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": "60; 1200"
}

Related drugs

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