🇺🇸
United States · US · US:58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9
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 · 6
- ndc1158602853121 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602853211 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602853731 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1158602853961 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602853972 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1158602853985 BLISTER PACK in 1 CARTON (58602-853-98) / 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": "58602-853_af251c56-1fce-46a6-bd52-cca3425b96f9",
"productndc": "58602-853",
"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": "20200813",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code R05CA03.
- 🇺🇸12 Hour Mucus ReliefCHAIN DRUG MARKETING ASSOCIATION INC
- 🇺🇸365 WHOLE FOODS MARKET GUAIFENESINWhole Foods Market, Inc.
- 🇺🇸Adult TussinCamber Consumer Care
- 🇺🇸Air PowerSchwabe North America, Inc
- 🇺🇸AkinSouthern Sales & Service, Inc.
- 🇺🇸Akin Expectorant Formula Strawberry BananaSouthern Sales & Service, Inc.
- 🇺🇸Always Save Chest Congestion ReliefValu Merch
- CABALMINIL EXPECTORANT (SUCROSE FREE)TEVA CANADA LIMITED
Access this data programmatically
Query Guaifenesin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.