🇺🇸
United States · US · US:41415-994_a36d0524-b1d7-4daf-a62e-54f63168b0cd
Guaifenesin and Pseudoephedrine Hydrochloride
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 · 2
- ndc1141415994181 BLISTER PACK in 1 CARTON (41415-994-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1141415994362 BLISTER PACK in 1 CARTON (41415-994-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A212542
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": "41415-994_a36d0524-b1d7-4daf-a62e-54f63168b0cd",
"productndc": "41415-994",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212542",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG;60MG",
"product_no": "001",
"approval_date": "Apr 28, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM;120MG",
"product_no": "002",
"approval_date": "Apr 28, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Guaifenesin and Pseudoephedrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA212542",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20220407",
"active_numerator_strength": "600; 60"
}Related drugs
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