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 5 of 47 · 922 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
unii: R16CO5Y76E
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
unii: R16CO5Y76E
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
unii: R16CO5Y76E
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
unii: R16CO5Y76E
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
unii: R16CO5Y76E
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
unii: R16CO5Y76E
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
unii: R16CO5Y76E
LOW DOSE ASPIRINASPIRINFamora Inc.4dc6f119-bbde-db5f-e063-6294a90a94862026-06-16WarningsExact identifier
unii: R16CO5Y76E
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact identifier
unii: R16CO5Y76E
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
unii: R16CO5Y76E
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLC.5401e4ff-aa7a-3e97-e063-6294a90a24f02026-06-11Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLC2f05947f-a489-4298-a871-90db75b2a6c52026-06-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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