Home NDC 69168-270 Sinus Headache PEMaximum Strength Non-Drowsy
Product NDC 69168-270
11-digit product format 691680270
Labeler code 69168
Product ID 69168-270_5614edd7-fae9-4261-aa48-bd393f771caa
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-22
Marketing end 2027-10-31
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 5 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Sinus Headache PEMaximum Strength Non-Drowsy
Brand name suffix Maximum Strength Non-Drowsy Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1046378 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-270-95 Sinus Headache PEMaximum Strength Non-DrowsyMaximum Strength Non-Drowsy 18 in 1 BLISTER PACK TABLET 18 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-270 SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH] 6 Current NDC, Legacy NDC, 1 package rows 20231114_b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f.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 1 of 85 · 1,681 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 69168-270-95 69168027095 18 TABLET in 1 BLISTER PACK (69168-270-95) 18 tablet 2014-12-22 2027-10-31 No No Current