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 76 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine hydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEDISCOUNT DRUG MART7668ad20-1ca7-4d93-b3a3-03cfde141f862019-03-19WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDESafeway Inc.01a5d9dd-f123-443b-b968-412c0aadaaa22019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEChain Drug Marketing Association Inc.880d368f-0ce3-4993-b5b1-13bf013105162019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc9a6ece8b-7036-4cad-aeb3-993ef4bf614f2019-03-14WarningsExact identifier
unii: 6V9V2RYJ8N
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
unii: 495W7451VQ
Severe Cold Head CongestionACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.3a774544-1994-4a93-9da9-06e55b1a83c82018-12-13WarningsExact identifier
unii: 495W7451VQ
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr.Reddy's Laboratories Limited25cca459-fdd6-3847-2207-dd4f019781b52018-12-05WarningsExact identifier
unii: 6V9V2RYJ8N
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECHAIN DRUG CONSORTIUM,LLC0f5de86d-1c87-4664-83f6-4c17f78f7d352018-11-30WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANY310d14be-e7ea-44b8-8b04-cffa39440d502018-10-27WarningsExact identifier
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.8cf0b878-ec13-fd44-d56f-f44af7c249ed2018-10-01WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESIN 200 MGRichmond Pharmaceuticals, Inc.e20927a1-d402-48c1-ba00-0745ddd0a0e72018-08-13WarningsExact identifier
unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEH E B5167ab78-f898-47ec-8baf-843269469d102018-07-18WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESIN 200 MGAphena Pharma Solutions - Tennessee, LLC2ae3c1e1-2a12-444d-a763-590320d373e12018-07-18WarningsExact identifier
unii: 495W7451VQ
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy02476e5a-0463-4223-8dc5-8bbe787d38dc2018-05-31WarningsExact identifier
unii: 6V9V2RYJ8N
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Extended-Release 600 mgGUAIFENESINGuardian Drug Company20f9e083-419d-429d-a570-24b312ed5d2a2018-02-28WarningsExact identifier
unii: 495W7451VQ
Childrens Multi-symptom Cold and Fever LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.7bf30c75-e867-4a2f-a481-702d7aa96c232018-01-08WarningsExact identifier
unii: 495W7451VQ
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINAphena Pharma Solutions - Tennessee, LLC1c84bf00-ebaa-4e69-a2c6-716631d209d92017-12-18WarningsExact identifier
unii: 495W7451VQ
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIThe Kroger Co.cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca62017-12-07WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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