Home NDC 69168-271 Decongestant PE
Product NDC 69168-271
11-digit product format 691680271
Labeler code 69168
Product ID 69168-271_2b621db5-4138-44f0-9c86-28468ba954af
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Decongestant PE
Brand name suffix Non Drowsy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299145 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-271-17 Decongestant PENon Drowsy 300 in 1 BOTTLE TABLET 300 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-271 DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC, 1 package rows 20231114_7a3098b4-381c-4f32-97a7-87b53fd64428.zip
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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69168-271-17 69168027117 300 TABLET in 1 BOTTLE (69168-271-17) 300 tablet 2021-06-16 0000-00-00 No No Current