FDA.reportPublic FDA data

NDC 69339-150-01 - Guaifenesin Syrup and Dextromethorphan

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
69339-150
Requested NDC
69339-150-01
Package NDCs from labels
69339-150-01, 69339-150-19
Manufacturer
Natco Pharma USA LLC
Effective date
2023-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guaifenesin Syrup and Dextromethorphan - Natco Pharma USA LLCNatco Pharma USA LLC2023-11-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-150-01Guaifenesin Syrup and Dextromethorphan10 mL in 1 CUP, UNIT-DOSESYRUP106
69339-150-19Guaifenesin Syrup and Dextromethorphan10 in 1 TRAYSYRUP106
69339-150-19Guaifenesin Syrup and Dextromethorphan10 in 1 CASESYRUP106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-150GUAIFENESIN SYRUP AND DEXTROMETHORPHAN SYRUP [NATCO PHARMA USA LLC]6Current NDC, Legacy NDC, 3 package rows20231102_ad9026f4-f0b6-4d02-aa44-f0460eeefc0e.zip

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 82 of 319 · 6,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
unii: L7T10EIP3A
Eucalyptol, Menthol, Methyl salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC1de7b114-37a4-4739-a241-7fc8e57066b42026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC454065e4-5ccf-4c01-861b-8f0ca2cd23b62026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLStrategic Sourcing Services LLC03c7e7f3-f72d-49c8-96ca-1d7422413ab42026-02-17Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Cold and Flu Severe, Day, NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.6e6bae79-1231-4b74-81c1-f0c914ed4af32026-02-17WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3fb49f64-2d77-44db-8186-5904837eedbe2026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
MUCUS AND CHEST CONGESTIONGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf341aa99-5339-4087-a98a-469231dfc6d02026-02-17WarningsExact identifier
unii: 495W7451VQ
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e12026-02-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Company117b44ba-5313-40f6-97c4-035a7f039fae2026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLValu Merchandisers Company93992f56-2e13-40d8-8e27-1f3989dd4c632026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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