Home NDC 0280-0160-01 Alka-Seltzer Heartburn and Pain
Product NDC 0280-0160
Requested package NDC 0280-0160-01
11-digit product format 002800160
Labeler code 0280
Product ID 0280-0160_2928e140-c867-5bf5-e063-6394a90ab024
Type HUMAN OTC DRUG
Nonproprietary name ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-03
Substance ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE
Active strength 1000; 325; 1916 mg/1; mg/1; mg/1
Pharmacologic classes Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Alka-Seltzer Heartburn and Pain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANHYDROUS CITRIC ACID 1000 mg/1 ASPIRIN 325 mg/1 SODIUM BICARBONATE 1916 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XF417D3PSL Internal UNII lookup R16CO5Y76E Internal UNII lookup 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1536675 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 0280-0160-01 Alka-Seltzer Heartburn and Pain 2 in 1 POUCH TABLET, EFFERVESCENT 2 1 0280-0160-01 Alka-Seltzer Heartburn and Pain 58 in 1 CARTON TABLET, EFFERVESCENT 58 1 0280-0160-02 Alka-Seltzer Heartburn and Pain 6 in 1 CARTON TABLET, EFFERVESCENT 6 1 0280-0160-02 Alka-Seltzer Heartburn and Pain 2 in 1 POUCH TABLET, EFFERVESCENT 2 1 0280-0160-03 Alka-Seltzer Heartburn and Pain 12 in 1 CARTON TABLET, EFFERVESCENT 12 1 0280-0160-03 Alka-Seltzer Heartburn and Pain 2 in 1 POUCH TABLET, EFFERVESCENT 2 1 0280-0160-04 Alka-Seltzer Heartburn and Pain 18 in 1 CARTON TABLET, EFFERVESCENT 18 1 0280-0160-04 Alka-Seltzer Heartburn and Pain 2 in 1 POUCH TABLET, EFFERVESCENT 2 1 0280-0160-05 Alka-Seltzer Heartburn and Pain 36 in 1 CARTON TABLET, EFFERVESCENT 36 1 0280-0160-05 Alka-Seltzer Heartburn and Pain 2 in 1 POUCH TABLET, EFFERVESCENT 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0160 ALKA-SELTZER HEARTBURN AND PAIN (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 1 Current NDC, 10 package rows 20250204_2928e140-c868-5bf5-e063-6394a90ab024.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 Sample Exclude flag Status 0280-0160-01 00280016001 58 POUCH in 1 CARTON (0280-0160-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 58 pouch 2025-02-03 No No Current