🇺🇸
United States · US · US:56062-614_6e895cf0-1ff9-464a-b315-49c0cab394fb
nasal and chest decongestant
Orange BookUNIISPLATC R05CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPublix Super Markets Inc
CountryUS (United States)
ATC codeR05CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1156062614624 BLISTER PACK in 1 CARTON (56062-614-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A214407
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": {
"0ae25bc9-5d90-4dd8-9620-8684c4fd9d37": {
"match": "brand_token",
"title": "NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [RUGBY LABORATORIES]",
"spl_version": "5",
"published_date": "2026-05-25"
}
},
"productid": "56062-614_6e895cf0-1ff9-464a-b315-49c0cab394fb",
"productndc": "56062-614",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "214407",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Feb 1, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Feb 1, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "nasal and chest decongestant",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214407",
"marketing_category": "ANDA",
"nonproprietary_name": "guaifenesin, pseudoephedrine hydrochloride",
"start_marketing_date": "20260402",
"active_numerator_strength": "1200; 120"
}Related drugs
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