Home NDC 83059-0162 Allergy plus Sinus Headache
Product NDC 83059-0162
11-digit product format 830590162
Labeler code 83059
Product ID 83059-0162_5b3d25c2-6780-4701-e063-6394a90abb19
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-11
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 12.5; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Allergy plus Sinus Headache
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83059-0162-1 83059016201 1 BLISTER PACK in 1 CARTON (83059-0162-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-09-11 No No Current