FDA.reportPublic FDA data

NDC 53666-403-33 - Alka Seltzer

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
53666-403
Requested NDC
53666-403-33
Package NDCs from labels
53666-403-33, 53666-403-15
Manufacturer
Salimex, S.A. | Bayer de Mexico, S.A. de CV
Effective date
2012-11-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alka Seltzer - Salimex, S.A. | Bayer de Mexico, S.A. de CVSalimex, S.A. | Bayer de Mexico, S.A. de CV2012-11-09HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53666-403-152021-01-29C16284748780-19855d018-d559-cd31-e053-dbdaa90ab51aAlka Seltzer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53666-403-15Alka Seltzer150 in 1 CASETABLET, EFFERVESCENT1503
53666-403-33Alka Seltzer12 in 1 BOXTABLET, EFFERVESCENT123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53666-403ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3Legacy NDC, 2 package rows20121114_73e85be6-1236-453b-b41c-37381a054773.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSLALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3
ASPIRINACTIVE INGREDIENTR16CO5Y76EALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3
ASPIRINACTIVE MOIETYR16CO5Y76EALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q20ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3

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 9 of 47 · 922 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspirinASPIRINAkron Pharma Inc.e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed2026-04-10WarningsExact identifier
unii: R16CO5Y76E
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
unii: R16CO5Y76E
Care One migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerican Sales Companybe6c9dc5-853e-4342-ba6a-e5b7be5afe722026-04-09WarningsExact identifier
unii: R16CO5Y76E
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
unii: R16CO5Y76E
Bayer Genuine AspirinASPIRINNavajo Manufacturing Company Inc.f6f2ce71-5728-aefb-e053-6394a90a20e42026-04-08WarningsExact identifier
unii: R16CO5Y76E
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
unii: R16CO5Y76E
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: R16CO5Y76E
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea9f4498-0d43-4043-8dd1-f22537841c212026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.8664c7ce-707b-4c6c-9ce4-7160b5f877f82026-04-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Pain Relief Aspirin Low DoseASPIRINRite Aid Corporation503408ed-e799-48a0-8d38-3034f4a0ead52026-04-02WarningsExact identifier
unii: R16CO5Y76E
Aspirin 81 mgASPIRINLidl US LLC468f4a2f-60f7-4808-95d7-a00be1bb112f2026-04-02WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low DoseASPIRINCOSTCO WHOLESALE CORPORATIONc8a8986b-1ab4-9da0-71da-42595db08b442026-04-02WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINCardinal Health 110, LLC. DBA Leader318cc982-23a9-4804-b6fb-248f772d7a382026-04-02WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINDiscount Drug Mart4a1e9c79-5036-4c69-82f9-e48abc972b472026-04-02WarningsExact identifier
unii: R16CO5Y76E
WispirinASPIRINWisdrug AG4e70ec5e-d033-a525-e063-6394a90a5a932026-04-01WarningsExact identifier
unii: R16CO5Y76E
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leaderef2d75ee-9ed7-4b53-adbc-2ec40364da632026-03-31WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINRMT HEALTH LLC4dc7229d-c895-1f80-e063-6394a90abfc32026-03-30WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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