FDA.reportPublic FDA data

NDC 53666-218-12 - Alka-Seltzer Original

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53666-218
Requested NDC
53666-218-12
Package NDCs from labels
53666-218-12, 53666-218-13, 53666-218-14
Manufacturer
SALIMEX, S.A. | Bayer de México, S.A. de C.V.
Effective date
2021-07-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alka-Seltzer OriginalSALIMEX, S.A. | Bayer de México, S.A. de C.V.2021-07-02HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53666-218-142022-07-29C16284748780-19d75b9d0-8d25-f424-e053-dadaa90a57ceAlka-Seltzer Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53666-218-12Alka-SeltzerOriginal2 in 1 POUCHTABLET23
53666-218-13Alka-SeltzerOriginal6 in 1 BOXTABLET63
53666-218-14Alka-SeltzerOriginal150 in 1 BOXTABLET1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53666-218ALKA-SELTZER ORIGINAL (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET [SALIMEX, S.A.]3Legacy NDC, 3 package rows20210729_5aa8704d-ab95-62f0-e053-2991aa0a5ed2.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 55 · 1,082 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
unii: R16CO5Y76E
Aspirin Regular StrengthASPIRINCardinal Health 110, LLC. DBA Leader2777beea-06d7-4ff5-ae4a-ad7a117dfb622026-09-02WarningsExact identifier
unii: R16CO5Y76E
Adult Low Dose Chewable AspirinASPIRINFarmacias De Similares TX LLC513ea306-74c6-96e3-e063-6394a90a82622026-09-01WarningsExact identifier
unii: R16CO5Y76E
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
butalbital, aspirin, and caffeineBUTALBITAL, ASPIRIN, AND CAFFEINEChartwell RX, LLCe69d8bb1-ba09-42e2-8372-7f5e0a9061742026-09-01Warnings, Adverse reactionsExact identifier
unii: R16CO5Y76E
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
unii: R16CO5Y76E
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
unii: R16CO5Y76E
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: R16CO5Y76E
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: R16CO5Y76E
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: R16CO5Y76E
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
unii: R16CO5Y76E
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
unii: R16CO5Y76E
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
unii: R16CO5Y76E
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mgASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLEMajor Pharmaceuticalsa6e652e1-b2e4-47ba-bed2-c5e902f8b8f12026-08-19Warnings, Adverse reactionsExact identifier
unii: R16CO5Y76E
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.