FDA.reportPublic FDA data

NDC 52904-455-02 - Sinus Relief Severe Congestion

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
52904-455
Requested NDC
52904-455-02
Package NDCs from labels
52904-455-02, 52904-455-06, 52904-455-50
Manufacturer
Select Corporation | ULTRAtab Laboratories, Inc.
Effective date
2012-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACETAMINOPHEN - Select Corporation | ULTRAtab Laboratories, Inc.Select Corporation | ULTRAtab Laboratories, Inc.2012-10-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-455-502023-01-30C16284748780-1f386c64a-3ba2-0266-e053-dadaa90a7c1a9196d2e1-c3ef-4b46-b10b-bbab08229cbb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-455-02Sinus Relief Severe Congestion2 in 1 PACKETTABLET22
52904-455-06Sinus Relief Severe Congestion1 in 1 CARTONTABLET12
52904-455-50Sinus Relief Severe Congestion25 in 1 BOXTABLET252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-455SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]2Legacy NDC, 3 package rows20180210_9196d2e1-c3ef-4b46-b10b-bbab08229cbb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]1

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 230 · 4,600 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: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsExact identifier
unii: 362O9ITL9D
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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