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United States · US · US:0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeR05DA
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
A207602
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": "0031-8765_158a1612-05f6-cc2e-e063-6294a90ab9ef",
"productndc": "0031-8765",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207602",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;1.2GM",
"product_no": "001",
"approval_date": "Mar 5, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG;600MG",
"product_no": "002",
"approval_date": "Mar 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Robitussin Maximum Strength 12 Hour Cough and Mucus Relief",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207602",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextromethorphan Hydrobromide, Guaifenesin",
"start_marketing_date": "20190614",
"active_numerator_strength": "60; 1200"
}Related drugs
Other records sharing ATC code R05DA.
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