FDA.reportPublic FDA data

TYLENOL COLD PLUS FLU SEVERE

Product NDC
29485-8060
11-digit product format
294858060
Labeler code
29485
Product ID
29485-8060_e4b87ba0-db76-2196-e053-2a95a90a074b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Mechanical Servants LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-04-18
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct29485-8060DDiscontinued by firm2026-10-05
excluded packagepackage29485-806029485-8060-4DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-8060TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL, GUAIFENESIN) TABLET TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL, GUAIFENESIN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]9Legacy NDC20250101_d3315908-ebc3-e7cd-e053-2a95a90ae9a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29485-8060-4294858060042 POUCH in 1 PACKAGE (29485-8060-4) > 2 TABLET in 1 POUCH2 pouch2017-04-180000-00-00NoNoCurrent