Home NDC 0280-0097 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels
Product NDC 0280-0097
11-digit product format 002800097
Labeler code 0280
Product ID 0280-0097_47e323f5-7f72-a31e-e063-6394a90af3a9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide , Doxylamine Succinate, Phenylephrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-25
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE
Active strength 325; 10; 5; 6.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1297288 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 0280-0097-01 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 10 0280-0097-01 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 10 0280-0097-02 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 10 0280-0097-02 Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0097 ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] 9 Current NDC, Legacy NDC, 4 package rows 20240821_e17eb929-209d-a2d1-e053-2a95a90a4cf3.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 0280-0097-01 00280009701 2 BLISTER PACK in 1 CARTON (0280-0097-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2021-08-25 0000-00-00 No No Current 0280-0097-02 00280009702 2 BLISTER PACK in 1 CARTON (0280-0097-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2021-08-25 0000-00-00 No No Current