🇺🇸
United States · US · US:36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d
Topco Mucus Relief
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTopco Associates, LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc113680022616100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A209215
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": {
"ecf87660-f552-1f6b-e053-2a95a90a2486": {
"match": "brand_token",
"title": "TOPCO ASSOCIATES (SELENIUM SULFIDE) SHAMPOO [TOPCO ASSOCIATES]",
"spl_version": "5",
"published_date": "2026-05-11"
}
},
"productid": "36800-226_201dbdbd-483f-46ee-8db2-e540d0b5cb9d",
"productndc": "36800-226",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209215",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Sep 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Sep 6, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Topco Mucus Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209215",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20210601",
"active_numerator_strength": "600"
}Related drugs
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