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United States · US · US:58602-810_e6952325-704d-4774-847c-02a6feb77434
Guaifenesin
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1158602810121 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602810211 BOTTLE in 1 CARTON (58602-810-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602810388 BLISTER PACK in 1 CARTON (58602-810-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602810731 BOTTLE in 1 CARTON (58602-810-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602810961 BLISTER PACK in 1 CARTON (58602-810-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602810972 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602810985 BLISTER PACK in 1 CARTON (58602-810-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
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": {
"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": "58602-810_e6952325-704d-4774-847c-02a6feb77434",
"productndc": "58602-810",
"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": "Guaifenesin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210453",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20191021",
"active_numerator_strength": "600"
}Related drugs
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