NDC 35418-119-42 - Cough Syrup DM

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
35418-119
Requested NDC
35418-119-42
Package NDCs from labels
35418-119-42, 35418-119-37
Manufacturer
Zee Medical Inc | Ultratab Laboratories, Inc.
Effective date
2023-01-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cough Syrup DM - Zee Medical Inc | Ultratab Laboratories, Inc.Zee Medical Inc | Ultratab Laboratories, Inc.2023-01-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-119-372023-01-06C16284748780-1ba0f9c33-1485-a910-e053-dadaa90a0b85Drug Facts
35418-119-372021-01-29C16284748780-1ba0f9c33-1485-a910-e053-dadaa90a0b85Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH SYRUP DM (GUAIFENESIN, DEXTROMETHORPHAM HBR) SYRUP [ZEE MEDICAL 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 150 · 2,997 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: 9D2RTI9KYH
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: 9D2RTI9KYH
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: 9D2RTI9KYH
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
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: 9D2RTI9KYH
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
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: PDC6A3C0OX
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
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: 9D2RTI9KYH
unii: 495W7451VQ
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 9D2RTI9KYH
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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