🇺🇸
United States · US · US:51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813
Guaifenesin 600 mg
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151316008015 BLISTER PACK in 1 CARTON (51316-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A215932
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": "51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813",
"productndc": "51316-008",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215932",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Mar 15, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "Mar 15, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "Guaifenesin 600 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215932",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20220901",
"active_numerator_strength": "600"
}Related drugs
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