Nasal Decongestant

Product NDC
68016-757
Requested package NDC
68016-757-24
11-digit product format
680160757
Labeler code
68016
Product ID
68016-757_71b68c2c-bda6-4f1c-a397-ad2b8aa8e17e
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-01-14
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 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 packagepackage68016-75768016-757-24DDiscontinued by firm2026-10-15

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
68016-757NASAL DECONGESTANT MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]11Legacy NDC20250312_b17929c8-d3e2-41f3-a5d4-c93b0f4f27f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-757-24680160757241 BLISTER PACK in 1 CARTON (68016-757-24) > 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-01-140000-00-00NoNoCurrent