FDA.reportPublic FDA data

NDC 67060-106-02 - COLD TABS II

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
67060-106
Requested NDC
67060-106-02
Package NDCs from labels
67060-106-02, 67060-106-68
Manufacturer
ADVANCED FIRST AID, INC. | ULTRA SEAL CORPORATION | ULTRA TAB LABORATORIES, INC.
Effective date
2016-10-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COLD TABS IIADVANCED FIRST AID, INC. | ULTRA SEAL CORPORATION | ULTRA TAB LABORATORIES, INC.2016-10-25HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67060-106-682023-01-30C16284748780-1f386c649-da88-0266-e053-dadaa90a7c1acdbe0b3a-ced3-465c-92a1-a526bbd07f09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67060-106-02COLD TABS II2 in 1 PACKETTABLET22
67060-106-68COLD TABS II100 in 1 CARTONTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67060-106COLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]2Legacy NDC, 2 package rows20161025_cdbe0b3a-ced3-465c-92a1-a526bbd07f09.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD TABS II (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ADVANCED FIRST AID, INC.]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 233 · 4,660 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
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
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

Reported adverse events (FAERS/openFDA)#

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