NDC 50201-0421

Bromo Seltzer

Aspirin, Sodium Bicarbonate, Citric Acid

Bromo Seltzer is a Oral Tablet, Effervescent in the Human Otc Drug category. It is labeled and distributed by Tower Laboratories Ltd. The primary component is Sodium Bicarbonate; Anhydrous Citric Acid; Aspirin.

• Product ID: 50201-0421_60b769f7-eab1-1a00-e053-2a91aa0ab7a7
• NDC: 50201-0421
• Product Type: Human Otc Drug
• Proprietary Name: Bromo Seltzer
• Generic Name: Aspirin, Sodium Bicarbonate, Citric Acid
• Dosage Form: Tablet, Effervescent
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-16
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part343
• Labeler Name: Tower Laboratories Ltd
• Substance Name: SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN
• Active Ingredient Strength: 1916 mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 50201-0421-2

20 TABLET, EFFERVESCENT in 1 CARTON (50201-0421-2)

• Marketing Start Date: 2012-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50201-0421-2 [50201042102]

Bromo Seltzer TABLET, EFFERVESCENT

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-16

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM BICARBONATE	1916 mg/1

OpenFDA Data

• SPL SET ID: 8ff88ee1-e33e-4051-992f-24e2720c48ce
• Manufacturer:
  • Tower Laboratories Ltd
• UNII:
  • 8MDF5V39QO
  • XF417D3PSL
  • R16CO5Y76E
• RxNorm Concept Unique ID - RxCUI:
  • 1537012
  • 1536675
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

NDC Crossover Matching brand name "Bromo Seltzer" or generic name "Aspirin, Sodium Bicarbonate, Citric Acid"

NDC	Brand Name	Generic Name
50201-0421	Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID
37205-196	Effervescent Antacid and Pain Relief	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID