Home NDC 29485-5043 24/7 Life Cold and Flu DayTime Severe
Product NDC 29485-5043
11-digit product format 294855043
Labeler code 29485
Product ID 29485-5043_ef1add63-964b-d49b-e053-2a95a90a7cdd
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mechanical Servants, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-10-27
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29485-5043 24/7 LIFE COLD AND FLU DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] 5 Legacy NDC 20250101_ef1add63-964a-d49b-e053-2a95a90a7cdd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 29485-5043-6 29485504306 6 BLISTER PACK in 1 CARTON (29485-5043-6) > 6 TABLET, FILM COATED in 1 BLISTER PACK 6 blister pack 2021-10-27 0000-00-00 No No Current