Sinus Pressure and Pain

Product NDC: 68016-173
11-digit product format: 680160173
Labeler code: 68016
Product ID: 68016-173_efb75b29-de2c-0c45-e053-2995a90ad5ee
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e0ef968-dff3-4446-8412-8085677332f0
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-09-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68016-173		D	Discontinued by firm		2026-10-12
excluded package	package	68016-173	68016-173-24	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
68016-173	SINUS PRESSURE AND PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HTTPS://DAILYMED.NLM.NIH.GOV/DAILYMED/DRUGINFO.CFM?SETID=5E0EF968-DFF3-4446-8412-8085677332F0]	4	Legacy NDC	20241013_ef8a3d1c-dd28-4535-a8cb-4d31c0773aff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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
68016-173-24	68016017324	2 BLISTER PACK in 1 CARTON (68016-173-24) > 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
1120B-PRV-2020-0903	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e0ef968-dff3-4446-8412-8085677332f0	2024-10-11	HUMAN OTC DRUG LABEL	4