bromo seltzer

Generic: aspirin, sodium bicarbonate, citric acid

Labeler: tower laboratories ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bromo seltzer
Generic Name aspirin, sodium bicarbonate, citric acid
Labeler tower laboratories ltd
Dosage Form TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients

anhydrous citric acid 1000 mg/1, aspirin 325 mg/1, sodium bicarbonate 1916 mg/1

Manufacturer
Tower Laboratories Ltd

Identifiers & Regulatory

Product NDC 50201-0421
Product ID 50201-0421_26d12ab7-a1ea-fb79-e063-6394a90a81e4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2012-07-16

Pharmacologic Class

Established (EPC)
calculi dissolution agent [epc] anti-coagulant [epc] nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc]
Mechanism of Action
acidifying activity [moa] calcium chelating activity [moa] cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]
Physiologic Effect
decreased coagulation factor activity [pe] decreased prostaglandin production [pe] decreased platelet aggregation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 502010421
Hyphenated Format 50201-0421

Supplemental Identifiers

RxCUI
1536675 1537012
UPC
0730637092108
UNII
XF417D3PSL R16CO5Y76E 8MDF5V39QO
NUI
N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bromo seltzer (source: ndc)
Generic Name aspirin, sodium bicarbonate, citric acid (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 325 mg/1
  • 1916 mg/1
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (50201-0421-2) / 2 TABLET, EFFERVESCENT in 1 POUCH
source: ndc

Packages (1)

50201-0421-2 10 POUCH in 1 CARTON (50201-0421-2) / 2 TABLET, EFFERVESCENT in 1 POUCH

Ingredients (3)

anhydrous citric acid (1000 mg/1) aspirin (325 mg/1) sodium bicarbonate (1916 mg/1)

Linked Drug Pages (1)

Bromo Seltzer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26d12ab7-a1ea-fb79-e063-6394a90a81e4", "openfda": {"nui": ["N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089", "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832"], "upc": ["0730637092108"], "unii": ["XF417D3PSL", "R16CO5Y76E", "8MDF5V39QO"], "rxcui": ["1536675", "1537012"], "spl_set_id": ["8ff88ee1-e33e-4051-992f-24e2720c48ce"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_pe": ["Decreased Coagulation Factor Activity [PE]", "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]"], "pharm_class_epc": ["Calculi Dissolution Agent [EPC]", "Anti-coagulant [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]"], "pharm_class_moa": ["Acidifying Activity [MoA]", "Calcium Chelating Activity [MoA]", "Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Tower Laboratories Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (50201-0421-2)  / 2 TABLET, EFFERVESCENT in 1 POUCH", "package_ndc": "50201-0421-2", "marketing_start_date": "20120716"}], "brand_name": "Bromo Seltzer", "product_id": "50201-0421_26d12ab7-a1ea-fb79-e063-6394a90a81e4", "dosage_form": "TABLET, EFFERVESCENT", "pharm_class": ["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]"], "product_ndc": "50201-0421", "generic_name": "ASPIRIN, SODIUM BICARBONATE, CITRIC ACID", "labeler_name": "Tower Laboratories Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bromo Seltzer", "active_ingredients": [{"name": "ANHYDROUS CITRIC ACID", "strength": "1000 mg/1"}, {"name": "ASPIRIN", "strength": "325 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1916 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120716", "listing_expiration_date": "20261231"}