Sinus Pressure and Pain

Product NDC
68016-173
Requested package NDC
68016-173-24
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68016-17368016-173-24DDiscontinued by firm2026-10-05

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
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-173SINUS PRESSURE AND PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HTTPS://DAILYMED.NLM.NIH.GOV/DAILYMED/DRUGINFO.CFM?SETID=5E0EF968-DFF3-4446-8412-8085677332F0]4Legacy NDC20241013_ef8a3d1c-dd28-4535-a8cb-4d31c0773aff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-173-24680160173242 BLISTER PACK in 1 CARTON (68016-173-24) > 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-09-010000-00-00NoNoCurrent