FDA.reportPublic FDA data

NDC 62011-0475-01 - Guaifenesin and Pseudoephedrine Hydrochloride

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
62011-0475
Requested NDC
62011-0475-01
Package NDCs from labels
62011-0475-1, 62011-0475-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
Effective date
2022-02-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guaifenesin and Pseudoephedrine HydrochlorideSTRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.2022-02-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0475-1Guaifenesin and Pseudoephedrine Hydrochloride18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE182
62011-0475-1Guaifenesin and Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0475GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, Legacy NDC, 2 package rows20220210_d139fd8d-66fd-4484-8e78-ed90c505d999.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 37 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWal-Mart Stores,Inc.,a748d5ab-901c-47bb-8437-997542ecebfe2025-10-28WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
unii: 495W7451VQ
ED BRON GPGUAIFENESIN AND PHENYLEPHRINEEDWARDS PHARMACEUTICALS, INC.b1fca5aa-d877-45e0-b074-dcbc6af94ee32025-10-28WarningsExact identifier
unii: 495W7451VQ
Tussin DM Cough and Chest Congestion AdultDEXTROMETHORPHAN HBR, GUAIFENESINP & L Development, LLC4af67ba7-8892-442c-b9fb-80aba9140e052025-10-28WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)ddc18f31-acb2-4305-929a-f4746efd42242025-10-24WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Pseudoephedrine HCLGUAIFENESIN AND PSEUDOEPHEDRINE HCLDr. Reddys Laboratories Limited845a2dcc-9069-3141-ae13-f2063f36d1302025-10-24WarningsExact identifier
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Daytime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)17640528-c1f7-4881-ba86-bb3f488a952c2025-10-24WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC1539c3d4-d982-7d4e-e063-6394a90ad7d62025-10-21WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINMethod Pharmaceuticals, LLC312ce620-4841-7488-e054-00144ff88e882025-10-21WarningsExact identifier
unii: 495W7451VQ
SudoGestPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsd46577aa-7fd7-2130-6ed6-4b3f7562491f2025-10-21WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin 1200 mgGUAIFENESIN 1200 MGMARKSANS PHARMA LIMITEDfedf43d0-d6d1-4f50-bbab-396701e45cb22025-10-17WarningsExact identifier
unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEAcella Pharmaceuticals, LLC0c403f27-0b9b-4da3-a66b-1040eff1b2bf2025-10-15Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
unii: 6V9V2RYJ8N
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
unii: 6V9V2RYJ8N
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
unii: 6V9V2RYJ8N
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
unii: 495W7451VQ
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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