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 34 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCa6f750c8-8738-4965-a3ad-612c246110562025-11-18WarningsExact identifier
unii: 495W7451VQ
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
unii: 495W7451VQ
TYLENOL SINUS SEVEREACETAMINOPHENR J General Corporation2cbf7954-b28f-4d7b-b142-6c6c5c58b25d2025-11-17WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpc5ea5a7a-c806-e5e0-e053-2995a90a15e92025-11-17WarningsExact identifier
unii: 495W7451VQ
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.f701a6ae-200d-48dc-94e4-6bd3228f50d42025-11-15WarningsExact identifier
unii: 495W7451VQ
MULTI-SYMPTOM COLDDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb1fae7cc-4033-44bc-aa7c-ca3ceea51c7d2025-11-15WarningsExact identifier
unii: 495W7451VQ
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAmeriSource Bergen4a8df3c9-bed3-4371-a1c1-59afe12203e22025-11-14WarningsExact identifier
unii: 6V9V2RYJ8N
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
unii: 495W7451VQ
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
unii: 495W7451VQ
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack85b98fa3-376c-41a3-b3c1-0c739d903a222025-11-14Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.87ab4578-84de-475d-a4b0-eec969f172532025-11-13WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
unii: 495W7451VQ
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
unii: 495W7451VQ
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
unii: 495W7451VQ
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b72025-11-13WarningsExact identifier
unii: 495W7451VQ
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
unii: 495W7451VQ
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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