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 21 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRRugby Laboratories69cd399a-0103-4543-bb06-c7cccffe9cc42026-02-10WarningsExact identifier
unii: 495W7451VQ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
unii: 495W7451VQ
mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company440c0cf6-d63d-4523-b137-26f70adb977a2026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
foster and thrive mucus relief dGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC235a465c-3a5e-4775-92e9-e57fd8d9c9b42026-02-07WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESportpharm LLC3b5c81b7-7464-129f-e063-6294a90a48c02026-02-06WarningsExact identifier
unii: 6V9V2RYJ8N
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLSportpharm LLC909dacfa-50d3-4bcf-b2df-5405427cfaad2026-02-06WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSportpharm LLC3b5c5617-8499-7fc8-e063-6394a90aa86c2026-02-06WarningsExact identifier
unii: 495W7451VQ
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
unii: 495W7451VQ
up and up mucus reliefGUAIFENESINTarget Corporation7c1598f1-1236-48d2-861b-de4715e3f3d22026-02-05WarningsExact identifier
unii: 495W7451VQ
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
unii: 495W7451VQ
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
unii: 495W7451VQ
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1425a847-bf34-1795-e063-6294a90a85b62026-02-03WarningsExact identifier
unii: 6V9V2RYJ8N
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
unii: 495W7451VQ
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
unii: 495W7451VQ
mucus erGUAIFENESINHyVee Inc74136552-55b2-4dee-9c66-3f84e9dc63d62026-02-03WarningsExact identifier
unii: 495W7451VQ
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leaderebfcb699-3369-4697-9841-44015b1c98082026-02-02WarningsExact identifier
unii: 495W7451VQ
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINProficient Rx LP28b31f37-6896-40f5-8f3a-60c93c5c12782026-02-01WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLC88bc399a-2b71-45a7-bdfb-226ff1df05362026-01-30WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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