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 45 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINMeijer2d7aa3c1-5a4f-7197-e063-6394a90aff472025-05-21WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Extended ReleaseGUAIFENESINPUBLIX SUPER MARKETS, INC038e1801-b978-4a2e-ae8c-8803596ec09c2025-05-20WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINPublix Super Markets, Inc435e627c-b4f4-4214-904a-7527aab32cbf2025-05-20WarningsExact identifier
unii: 495W7451VQ
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINSDA Laboratories, Inc.1fd16b06-0c3e-4a30-ae6a-7b1632189c202025-05-16WarningsExact identifier
unii: 495W7451VQ
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
unii: 495W7451VQ
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINATLANTIC BIOLOGICALS CORP.8f496c61-41a6-41ba-80f5-7a5309c4d18b2025-05-12WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINAurohealth LLC4ec1477e-6e33-4c40-a476-cf7f4f00192b2025-05-08WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINAurohealth LLC30c27274-a051-4884-b41e-12943d92b1992025-05-08WarningsExact identifier
unii: 495W7451VQ
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
unii: 495W7451VQ
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEMeijer Distribution Inc4d431663-4b6a-4b00-9bbd-87d2c6b8ddad2025-05-04WarningsExact identifier
unii: 6V9V2RYJ8N
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter17eee39b-5a7a-ba20-e063-6294a90ac3922025-04-29WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter826d9c3c-7535-48bb-906e-d75e2ec670db2025-04-29WarningsExact identifier
unii: 495W7451VQ
Leader All Day Sinus and Cold DNAPROXEN SODIUM, PSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader83f7cfbb-ab84-4594-ae7a-4a657385c8a72025-04-25WarningsExact identifier
unii: 6V9V2RYJ8N
All Day Sinus and Cold DNAPROXEN SODIUM, PSEUDOEPHEDRINE HCLWalgreen Companyb0417ce5-3a5e-42cb-8672-9f2b133c91ca2025-04-25WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
unii: 6V9V2RYJ8N
GuaifenesinGUAIFENESINAMERISOURCE BERGENd1d94d37-4423-4914-9d86-c5ca6d5122f62025-04-22WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Extended ReleaseGUAIFENESINRugby Laboratories, Inc.8bc6f08e-a941-4fa8-8dd6-a699abf2337d2025-04-21WarningsExact identifier
unii: 495W7451VQ
Sinus and Cold DNAPROXEN SODIUM, PSEUDOEPHEDRINE HCLMeijer Distribution Inccb78330b-d8a3-4c16-bbb0-d31368a542e62025-04-18WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCbced0a2e-047e-456e-bbd2-495e83bf07ee2025-04-18WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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