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 74 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINDemoulas Super Markets, Ince8948cbe-1eca-490d-e053-2995a90a6ba12022-10-03WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthGUAIFENESINDemoulas Super Markets, Ince8948cbe-1ecc-490d-e053-2995a90a6ba12022-10-03WarningsExact identifier
unii: 495W7451VQ
sinus pressure and congestion relief maximum strengthPSEUDOEPHEDRINE HCLRite Aid Corporationaa52d998-cab8-439c-ac95-6c1f5da48ba42022-08-04WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin Extended ReleaseGUAIFENESINSAM'S WEST INC64297bb8-cd4e-46d3-ae79-ea4aa4c03bca2022-06-24WarningsExact identifier
unii: 495W7451VQ
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyabecb791-b635-482f-bb99-3ee4b7093e782022-06-24WarningsExact identifier
application number: ANDA212542
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
unii: 495W7451VQ
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.4dee850b-b170-4ef9-ae02-3db9bfa05abe2022-06-08WarningsExact identifier
application number: ANDA212542
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Mucus Relief DMMUCUS RELIEF DMTopCo Associates, LLC71674a9b-89ed-43d1-aadb-b9311fdfbdf92022-06-07WarningsExact identifier
unii: 495W7451VQ
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRKroger Company11b3c01a-93c5-4cd1-8422-d3c3d19d8dff2022-05-24WarningsExact identifier
unii: 495W7451VQ
GUAIFENESIN AND DEXTROMETHORPHAN HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRKroger Company8f7200ff-3e4d-414a-a1f9-fe8daac67cb12022-05-24WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMGood Sense26a199bf-57e5-4f36-b40c-83a1187e48702022-05-18WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
unii: 495W7451VQ
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH 110, LLC DBA LEADERa2189d7d-9335-4e96-8f6d-95c583739ac02022-05-12WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESINWinCo Foods, LLC90e72075-d08a-41c8-a6b0-5fbb99a7ea412022-05-11WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINWalmart Stores, Inc.794e383d-2cae-49d7-9c2d-ae5547bde5362022-05-09WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINKroger Companyd1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d2022-04-29WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Extended ReleaseGUAIFENESINKroger Companyd434656a-221b-40fc-81ad-2b698be1aa332022-04-20WarningsExact identifier
unii: 495W7451VQ
berkley and jensen mucus reliefGUAIFENESINBJWC433588eb-18ad-473f-9527-4947a143824e2022-04-19WarningsExact identifier
unii: 495W7451VQ
basic care mucus er maxGUAIFENESINAmazon.com Services LLC9ab3d192-0fd4-48fd-95ea-3182c63a73272022-04-12WarningsExact identifier
unii: 495W7451VQ
basic care mucus erGUAIFENESINAmazon.com Services LLC14213a15-5842-456f-a5ab-654268c58f782022-04-11WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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