Home NDC 29485-8055 TYLENOL SINUS SEVERE
Product NDC 29485-8055
11-digit product format 294858055
Labeler code 29485
Product ID 29485-8055_e43d9147-1863-1387-e053-2995a90acbb3
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 29485-8055-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 29485-8055-4 f5e01cc5f278…a2eaf40c39c3…
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 29485-8055 TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.] 8 Legacy NDC 20241101_d333b09f-b13e-5b41-e053-2995a90a3312.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 29485-8055-4 29485805504 2 POUCH in 1 BLISTER PACK (29485-8055-4) > 2 TABLET in 1 POUCH 2 pouch 2017-04-18 0000-00-00 No No Current