TYLENOL SINUS SEVERE

Product NDC: 29485-8057
11-digit product format: 294858057
Labeler code: 29485
Product ID: 29485-8057_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: 2017-08-22
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	29485-8057		D	Discontinued by firm	2026-10-12
excluded package	package	29485-8057	29485-8057-2	D	Discontinued by firm	2026-10-12
excluded package	package	29485-8057	29485-8057-3	D	Discontinued by firm	2026-10-12

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-8057	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]	8	Legacy NDC	20241101_d333b09f-b13e-5b41-e053-2995a90a3312.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-8057-2	29485805702	25 POUCH in 1 BOX (29485-8057-2) > 2 TABLET in 1 POUCH	25 pouch	2020-07-20	0000-00-00	No	No	Current
29485-8057-3	29485805703	30 POUCH in 1 BOX (29485-8057-3) > 2 TABLET in 1 POUCH	30 pouch	2017-08-22	0000-00-00	No	No	Current