🇺🇸
United States · US · US:0031-8754_159a0a07-055f-e1e2-e063-6394a90a9a37
Robitussin 12 Hour Cough Relief
Orange BookUNIISPLATC N07XX59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeN07XX59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9D2RTI9KYH",
"rxcui": "102490",
"inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
"display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"868ac65a-63e2-46ac-b87d-66b289086756": {
"match": "brand_token",
"title": "ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]",
"spl_version": "11",
"published_date": "2026-01-09"
}
},
"productid": "0031-8754_159a0a07-055f-e1e2-e063-6394a90a9a37",
"productndc": "0031-8754",
"dosage_form": "SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "091135",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG HYDROBROMIDE/5ML",
"product_no": "001",
"approval_date": "May 25, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"proprietary_name": "Robitussin 12 Hour Cough Relief",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA091135",
"marketing_category": "ANDA",
"nonproprietary_name": "dextromethorphan polistirex",
"start_marketing_date": "20160705",
"active_numerator_strength": "30"
}Related drugs
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