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 55 of 321 · 6,418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MARTd00e472f-78f2-3d36-e053-2995a90ac2672026-05-05WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MART Original Flavor MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MART73e1b1f3-01dd-4609-9825-b598c6745c732026-05-05WarningsExact identifier
unii: L7T10EIP3A
ALKA SELTZER COLD Cold Cough Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51173330-d537-fb9c-e063-6394a90ae3422026-05-05WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
unii: L7T10EIP3A
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc08e74a8d-8e8d-4cda-9adc-ea2ff40683532026-05-05WarningsExact identifier
application number: M012
Brompheniramine maleate, pseudoephedrine hydrochloride,BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,Eywa Pharma Inc8a4b2d13-d1c9-416f-95fd-f7d7b7970bb52026-05-05Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companye42f9e0d-f990-4c33-af43-75acf5d776382026-05-05WarningsExact identifier
application number: M012
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsExact identifier
application number: M012
unii: 495W7451VQ
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
application number: M012
Lidothol ESMENTHOL 5%, LIDOCAINE 4%Clinic Pharmab456b63b-cead-4bed-aa2e-881fe88a77dc2026-05-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
unii: L7T10EIP3A
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
COUGH DMDEXTROMETHORPHAN POLISTIREXSafeway58dab2f1-27b5-4522-bdc6-b710f20802eb2026-05-04WarningsExact identifier
unii: 9D2RTI9KYH
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
application number: M012
unii: 495W7451VQ
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINHarris Teeter, LLCf7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c2026-05-01WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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