🇺🇸
United States · US · US:0031-8726_159adf0d-831e-3d0e-e063-6394a90a40dd
Childrens 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": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "0031-8726_159adf0d-831e-3d0e-e063-6394a90a40dd",
"productndc": "0031-8726",
"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": "Childrens 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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