Home NDC 50201-0421 Bromo Seltzer
Product NDC 50201-0421
11-digit product format 502010421
Labeler code 50201
Product ID 50201-0421_26d12ab7-a1ea-fb79-e063-6394a90a81e4
Type HUMAN OTC DRUG
Nonproprietary name ASPIRIN, SODIUM BICARBONATE, CITRIC ACID
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Tower Laboratories Ltd
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-07-16
Substance SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN
Active strength 1916; 1000; 325 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 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 Bromo Seltzer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM BICARBONATE 1916 mg/1 ANHYDROUS CITRIC ACID 1000 mg/1 ASPIRIN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8MDF5V39QO Internal UNII lookup XF417D3PSL Internal UNII lookup R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1536675 Internal RxNorm lookup 1537012 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 50201-0421-2 Bromo Seltzer 10 in 1 CARTON TABLET, EFFERVESCENT 10 7 50201-0421-2 Bromo Seltzer 2 in 1 POUCH TABLET, EFFERVESCENT 2 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANHYDROUS CITRIC ACID ACTIVE INGREDIENT XF417D3PSL BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1 ANHYDROUS CITRIC ACID ACTIVE MOIETY XF417D3PSL BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50201-0421 BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD] 7 Current NDC, Legacy NDC, 2 package rows 20241212_8ff88ee1-e33e-4051-992f-24e2720c48ce.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 83 · 1,657 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 50201-0421-2 50201042102 10 POUCH in 1 CARTON (50201-0421-2) / 2 TABLET, EFFERVESCENT in 1 POUCH 10 pouch 2012-07-16 0000-00-00 No No Current