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 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 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 57 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join foster and thrive pain reliever ACETAMINOPHEN Strategic Sourcing Services LLC 338021bd-b92b-45eb-a4b8-bc4a100ab718 2024-11-06 Warnings Exact identifier application number: M013 basic care headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Amazon.com Services LLC f85d2f4c-8184-4555-a310-3979722e860b 2024-11-05 Warnings Exact identifier application number: M013 MENSTRUAL COMPLETE MENSTRUAL COMPLETE Allegiant Health d197b886-67e4-4aba-8582-305576c07604 2024-11-05 Warnings Exact identifier application number: M013 dg health headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp Inc ddf40cc4-d73f-4460-be72-9486134329a7 2024-11-05 Warnings Exact identifier application number: M013 DOLO- NeuroBion Acetaminophen 500mg ACETAMINOPHEN BENARD INDUSTRIES INC 16f8415d-8190-4212-b487-c0caf7d3bee2 2024-11-04 Warnings Exact identifier application number: M013 basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 8c3343ee-d7b6-496d-9702-6736539a7270 2024-11-02 Warnings Exact identifier application number: M013 dg health pain relief ACETAMINOPHEN Dolgencorp, LLC 382fa2cc-1c39-4bee-b528-08b11ec945af 2024-11-02 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack f7e20527-1d4b-434c-997b-3eb8211fdaa1 2024-11-01 Warnings Exact identifier application number: M013 Aspirin Enteric Safety Coated ASPIRIN Publix Supermarkets, Inc. a661a9ed-9b31-46b1-aafb-61d1ba8a4918 2024-11-01 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 614e69c7-d3cb-4d47-9603-c1c14b87544c 2024-11-01 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation baee03b8-fcfd-440e-90ea-1ee2a18516ef 2024-11-01 Warnings Exact identifier application number: M013 good neighbor pharmacy infants pain and fever ACETAMINOPHEN Amerisource Bergen bfb954b7-3a79-4bca-95e8-d39e1074b07f 2024-11-01 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE Proficient Rx LP bf365bfc-35cc-47f9-a50b-ff2b38d7316b 2024-11-01 Warnings Exact identifier application number: M013 Infants Pain Relief ACETAMINOPHEN Publix Super Markets Inc 0bc33897-afc2-4d11-be6c-a26480f448bf 2024-10-31 Warnings Exact identifier application number: M013 equate infants pain and fever ACETAMINOPHEN WALMART INC. 34b2512e-743b-45db-92cb-ea05e2f47b3d 2024-10-31 Warnings Exact identifier application number: M013 foster and thrive infants pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC 45770ad6-9bf7-41bd-a724-e5260cd31fa1 2024-10-31 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET Lil' Drug Store Products, Inc. d20425a4-f074-4154-e053-2995a90ae9fd 2024-10-30 Warnings Exact identifier application number: M013 up and up infants acetaminophen ACETAMINOPHEN Target Corporation 31104956-04d7-41b5-82be-219ded5c02a9 2024-10-30 Warnings Exact identifier application number: M013 Sunmark Aspirin ASPIRIN Strategic Sourcing Services LLC a7139686-b351-47dc-a395-832429aaa569 2024-10-30 Warnings Exact identifier application number: M013 Good Neighbor Pharmacy Pain Relief ACETAMINOPHEN Amerisource Bergen 5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1 2024-10-30 Warnings Exact identifier application number: M013
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