FDA.reportPublic FDA data

NDC 53666-408-12 - TABCIN 500

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
53666-408
Requested NDC
53666-408-12
Package NDCs from labels
53666-408-12, 53666-408-15
Manufacturer
Salimex, S.A. | Bayer de Mexico, S.A. de CV
Effective date
2013-09-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TABCIN 500 - Salimex, S.A. | Bayer de Mexico, S.A. de CVSalimex, S.A. | Bayer de Mexico, S.A. de CV2013-09-12HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53666-408-152020-01-31C16284748780-19d75b9d1-0720-f424-e053-dadaa90a57ceTABCIN 500

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53666-408-12TABCIN50012 in 1 BOXTABLET, EFFERVESCENT127
53666-408-15TABCIN500150 in 1 CASETABLET, EFFERVESCENT1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53666-408TABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7Legacy NDC, 2 package rows20130912_0039fee5-35a8-429b-a1cf-7b4bf1f8a6e7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ETABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZTABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
Phenylephrine BitartrateACTIVE INGREDIENT27O3Q5ML57TABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
ASPIRINACTIVE MOIETYR16CO5Y76ETABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UTABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTABCIN 500 (ACETYLSALICYLIC ACID, PHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]7

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 54 · 1,076 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: V1Q0O9OJ9Z
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Low Dose AspirinASPIRINStrategic Sourcing Services LLC7ce4807e-7bd5-41f1-a9c7-1f3af6acdc092026-09-09WarningsExact identifier
unii: R16CO5Y76E
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: V1Q0O9OJ9Z
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
unii: V1Q0O9OJ9Z
Aspirin Regular StrengthASPIRINCardinal Health 110, LLC. DBA Leader2777beea-06d7-4ff5-ae4a-ad7a117dfb622026-09-02WarningsExact identifier
unii: R16CO5Y76E
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: V1Q0O9OJ9Z
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
unii: V1Q0O9OJ9Z
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
unii: V1Q0O9OJ9Z
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
unii: V1Q0O9OJ9Z
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
unii: V1Q0O9OJ9Z
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
Allergy ReliefCHLORPHENIRAMINE MALEATEWALMART INC.5e6623c3-6210-4c50-94d6-5554f36876d12026-08-31WarningsExact identifier
unii: V1Q0O9OJ9Z
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
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
unii: V1Q0O9OJ9Z
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
unii: R16CO5Y76E

Reported adverse events (FAERS/openFDA)#

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