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 7 of 47 · 922 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL, ASPIRIN, AND CAFFEINEBUTALBITAL, ASPIRIN, AND CAFFEINEWestminster Pharmaceuticals, LLCac6ceec2-72d8-4901-9d30-278965a790492026-05-11Warnings, Adverse reactionsExact identifier
unii: R16CO5Y76E
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
rxcui: 1536675
unii: R16CO5Y76E
unii: XF417D3PSL
unii: 8MDF5V39QO
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
rxcui: 1536675
unii: R16CO5Y76E
unii: XF417D3PSL
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsExact identifier
unii: 8MDF5V39QO
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
unii: R16CO5Y76E
migraine formulaACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc76e21832-5c4c-4c73-9f87-1060abbd3d822026-05-08WarningsExact identifier
unii: R16CO5Y76E
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
unii: R16CO5Y76E
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
unii: R16CO5Y76E
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
unii: R16CO5Y76E
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: R16CO5Y76E
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
unii: R16CO5Y76E
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINBetter Living Brands, LLC5ebd04d8-52c7-4c72-a4c1-fc7fd488ea242026-05-06WarningsExact identifier
unii: R16CO5Y76E
Back and Body Extra StrengthASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leader519eb216-9fa6-4d60-a2a4-3310bdb5b4ab2026-05-06WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINGeiss, Destin & Dunn Inc.b8f6e486-5332-4c46-ab6c-7de04c91c60b2026-05-06WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low Dose Chewable OrangeASPIRINMajor Pharmaceuticals4ba6eed3-004a-4576-b7f7-685fae49cf6a2026-05-04WarningsExact identifier
unii: R16CO5Y76E
Back and BodyASPIRIN, CAFFEINEKroger Company366b58db-1ac3-427b-b42a-5f56a14e298c2026-05-01WarningsExact identifier
unii: R16CO5Y76E
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
unii: 8MDF5V39QO
Up and Up Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINETarget Corporationacaffae6-2964-4529-b61a-19ddfc5fd6692026-04-29WarningsExact identifier
unii: R16CO5Y76E
Acetaminophen , Aspirin and CaffeineACETAMINOPHEN , ASPIRIN AND CAFFEINESoftgel Healthcare Pvt Ltd4543e156-1deb-666e-e063-6394a90a719c2026-04-27WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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