NDC 53666-100

Alka Seltzer

Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate

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

Product ID53666-100_c5cec0f6-56ff-4544-a932-a133ad26c2d4
NDC53666-100
Product TypeHuman Otc Drug
Proprietary NameAlka Seltzer
Generic NameAspirin, Anhydrous Citric Acid, Sodium Bicarbonate
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2012-10-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart343
Labeler NameSalimex, S.A.
Substance NameASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53666-100-10

100 TABLET, EFFERVESCENT in 1 BOX (53666-100-10)
Marketing Start Date2012-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53666-100-10 [53666010010]

Alka Seltzer TABLET, EFFERVESCENT
Marketing CategoryOTC monograph final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-10-10
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ASPIRIN325 mg/1

OpenFDA Data

SPL SET ID:73e85be6-1236-453b-b41c-37381a054773
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1536680
  • 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 "Alka Seltzer" or generic name "Aspirin, Anhydrous Citric Acid, Sodium Bicarbonate"

    NDCBrand NameGeneric Name
    52642-226Alka SeltzerCalcium carbonate
    53666-100Alka SeltzerASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE
    53666-403Alka SeltzerASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE
    69842-542CVS Health Extra Strength Antacid and Pain RelieverAspirin, Anhydrous Citric Acid, Sodium Bicarbonate
    63868-569Quality Choice Extra Strength Effervescent Antacid and Pain ReliefAspirin, Anhydrous Citric Acid, Sodium Bicarbonate
    53666-444TABCINASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE

    Trademark Results [Alka Seltzer]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALKA SELTZER
    ALKA SELTZER
    78695208 not registered Dead/Abandoned
    Bayer HealthCare LLC
    2005-08-18
    ALKA SELTZER
    ALKA SELTZER
    71677971 0613450 Dead/Expired
    MILES LABORATORIES, INC.
    1954-12-08

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.