🇺🇸
United States · US · US:63868-149_2435b323-730e-a3fb-e063-6294a90a7498
12 Hour Mucus Relief
Orange BookUNIISPLATC R05CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCHAIN DRUG MARKETING ASSOCIATION INC
CountryUS (United States)
ATC codeR05CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163868149202 BLISTER PACK in 1 CARTON (63868-149-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
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": {
"d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
"match": "brand_token",
"title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
"spl_version": "2",
"published_date": "2026-04-24"
}
},
"productid": "63868-149_2435b323-730e-a3fb-e063-6294a90a7498",
"productndc": "63868-149",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213420",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "May 8, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.2GM",
"product_no": "002",
"approval_date": "May 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "GUAIFENESIN",
"proprietary_name": "12 Hour Mucus Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213420",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin",
"start_marketing_date": "20210917",
"active_numerator_strength": "600"
}Related drugs
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