Sinus plus Headache

Product NDC
41250-534
11-digit product format
412500534
Labeler code
41250
Product ID
41250-534_dcf4675c-0cac-7d99-e053-2995a90a18bd
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-10
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41250-534DDiscontinued by firm2026-10-05
excluded packagepackage41250-53441250-534-05DDiscontinued 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
41250-534SINUS PLUS HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MEIJER]4Legacy NDC20241013_a616acdc-08a5-ecdd-e053-2995a90ace63.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-534-05412500534052 BLISTER PACK in 1 CARTON (41250-534-05) > 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-07-100000-00-00NoNoCurrent