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 77 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIHEB0de7fc37-7f46-4e98-d5ac-d31a3c313a622017-12-07WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESIN 400 MGRichmond Pharmaceuticals, Inc.26924bee-32cc-4499-beb0-2650ff8eb1da2017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRRichmond Pharmaceuticals, Inc59b00858-e5c9-420a-bc7e-46953722cde62017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRAdvance Pharmaceutical Inc.e507a84a-59d5-47f2-a2df-f342e4b093b42017-10-30WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESIN 400 MGAdvance Pharmaceutical Inc.5b78bbe9-806c-443f-bc23-351e5342355f2017-10-30WarningsExact identifier
unii: 495W7451VQ
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 495W7451VQ
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL523561fb-f6a7-4cde-9be2-bba02e60e2082017-04-06WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL8aa32b2a-a8be-4f8d-9b1f-eb007bff8e652016-12-19WarningsExact identifier
unii: 495W7451VQ
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCICVS Pharmacy3e295047-1a46-a0d8-2e3f-ec4086f5aedb2015-08-24WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIWalgreens Company37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b32015-08-04WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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