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United States · US · US:0121-0638_c50b4c5c-6f55-4118-a282-e0b490704e49
GUAIFENESIN DM
UNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11012106380010 TRAY in 1 CASE (0121-0638-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05)
- ndc110121063804118 mL in 1 BOTTLE (0121-0638-04)
- ndc110121063808237 mL in 1 BOTTLE (0121-0638-08)
- ndc110121063816473 mL in 1 BOTTLE (0121-0638-16)
Annotations
UNII (FDA Substance ID)
7355X3ROTS
DEXTROMETHORPHAN
RxCUI 236146
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": {
"9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
"match": "brand_token",
"title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "0121-0638_c50b4c5c-6f55-4118-a282-e0b490704e49",
"productndc": "0121-0638",
"dosage_form": "SYRUP",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN; GUAIFENESIN",
"proprietary_name": "GUAIFENESIN DM",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "GUAIFENESIN and DEXTROMETHORPHAN",
"start_marketing_date": "19920701",
"active_numerator_strength": "10; 100"
}Related drugs
Other records sharing ATC code R05DA.
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