Codeine-Guaifenesin

Product NDC
71205-624
11-digit product format
712050624
Labeler code
71205
Product ID
71205-624_f2b561b1-fe8c-440e-a290-ef7522f7da7e
Type
HUMAN OTC DRUG
Nonproprietary name
Codeine Phosphate and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-15
Substance
CODEINE PHOSPHATE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
GSL05Y1MN6CODEINE PHOSPHATE41444-62-6CODEINE PHOSPHATE
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-624-0471205062404118 mL in 1 BOTTLE (71205-624-04) 118 ml2021-12-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Codeine-GuaifenesinProficient Rx LP2024-10-01HUMAN OTC DRUG LABEL2