🇺🇸
United States · US · US:58602-610_126b5a4d-b915-4fe8-9156-a94d729ac47d
DEXTROMETHORPHAN POLISTIREX
Orange BookUNIISPLATC N07XX59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeN07XX59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1158602610051 BOTTLE in 1 CARTON (58602-610-05) / 89 mL in 1 BOTTLE
- ndc1158602610061 BOTTLE in 1 CARTON (58602-610-06) / 148 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7355X3ROTS
DEXTROMETHORPHAN
RxCUI 236146
Orange Book
A218417
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7355X3ROTS",
"rxcui": "236146",
"inchikey": "MKXZASYAUGDDCJ-NJAFHUGGSA-N",
"display_name": "DEXTROMETHORPHAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4fde00af-3824-44f1-8a5f-d88518e0a8c8": {
"match": "brand_token",
"title": "DEXTROMETHORPHAN POLISTIREX SUSPENSION, EXTENDED RELEASE [AUROHEALTH LLC]",
"spl_version": "2",
"published_date": "2026-05-20"
}
},
"productid": "58602-610_126b5a4d-b915-4fe8-9156-a94d729ac47d",
"productndc": "58602-610",
"dosage_form": "SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "218417",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG HYDROBROMIDE/5ML",
"product_no": "001",
"approval_date": "Apr 15, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN",
"proprietary_name": "DEXTROMETHORPHAN POLISTIREX",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA218417",
"marketing_category": "ANDA",
"nonproprietary_name": "DEXTROMETHORPHAN POLISTIREX",
"start_marketing_date": "20260415",
"active_numerator_strength": "30"
}Related drugs
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