Home NDC 0280-0001 Alka-Seltzer Cool Action Heartburn Relief
Product NDC 0280-0001
11-digit product format 002800001
Labeler code 0280
Product ID 0280-0001_452374f2-bab8-ec4e-e063-6294a90adca9
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form GUM, CHEWING
Route ORAL
Labeler Bayer HealthCare LLC.
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-01
Substance CALCIUM CARBONATE
Active strength 750 mg/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 Alka-Seltzer Cool Action Heartburn Relief
Brand name suffix Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2281777 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 0280-0001-01 Alka-Seltzer Cool Action Heartburn ReliefMint 2 in 1 CARTON GUM, CHEWING 2 7 0280-0001-01 Alka-Seltzer Cool Action Heartburn ReliefMint 8 in 1 BLISTER PACK GUM, CHEWING 8 7 0280-0001-02 Alka-Seltzer Cool Action Heartburn ReliefMint 8 in 1 BLISTER PACK GUM, CHEWING 8 7 0280-0001-02 Alka-Seltzer Cool Action Heartburn ReliefMint 1 in 1 CARTON GUM, CHEWING 1 7 0280-0001-03 Alka-Seltzer Cool Action Heartburn ReliefMint 1 in 1 POUCH GUM, CHEWING 1 7 0280-0001-04 Alka-Seltzer Cool Action Heartburn ReliefMint 10 in 1 BLISTER PACK GUM, CHEWING 10 7 0280-0001-04 Alka-Seltzer Cool Action Heartburn ReliefMint 6 in 1 CARTON GUM, CHEWING 6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0001 ALKA-SELTZER COOL ACTION HEARTBURN RELIEF MINT (CALCIUM CARBONATE) GUM, CHEWING [BAYER HEALTHCARE LLC.] 6 Current NDC, Legacy NDC, 7 package rows 20241116_9b8da147-8d0c-e6b0-e053-2a95a90a35e6.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 8 of 34 · 678 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 0280-0001-01 00280000101 2 BLISTER PACK in 1 CARTON (0280-0001-01) / 8 GUM, CHEWING in 1 BLISTER PACK 2 blister pack 2020-03-01 0000-00-00 No No Current 0280-0001-02 00280000102 1 BLISTER PACK in 1 CARTON (0280-0001-02) / 8 GUM, CHEWING in 1 BLISTER PACK 1 blister pack 2020-05-01 0000-00-00 No No Current 0280-0001-03 00280000103 1 GUM, CHEWING in 1 POUCH (0280-0001-03) 2020-06-01 0000-00-00 No No Current 0280-0001-04 00280000104 6 BLISTER PACK in 1 CARTON (0280-0001-04) / 10 GUM, CHEWING in 1 BLISTER PACK 6 blister pack 2024-11-15 No No Current