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 20 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
unii: 495W7451VQ
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
unii: 495W7451VQ
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
unii: 495W7451VQ
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
unii: 495W7451VQ
Good Sense Mucus DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSportpharm LLC81fb0ce7-1b13-4b9d-8f98-671ffd9205c32026-02-23WarningsExact identifier
unii: 495W7451VQ
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
unii: 495W7451VQ
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSportpharm LLC2f170b35-03a8-4d2e-a4ea-21cccf693d9e2026-02-18WarningsExact identifier
unii: 495W7451VQ
sinus and nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe39daa3c-1901-4966-b85e-ab76d7bd12162026-02-17WarningsExact identifier
unii: 6V9V2RYJ8N
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862026-02-17WarningsExact identifier
unii: 495W7451VQ
MUCUS AND CHEST CONGESTIONGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf341aa99-5339-4087-a98a-469231dfc6d02026-02-17WarningsExact identifier
unii: 495W7451VQ
ALLERGY RELIEF D12CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5b6cd5ba-bdca-434e-b024-0089aeeec6a12026-02-17WarningsExact identifier
unii: 6V9V2RYJ8N
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e12026-02-17WarningsExact identifier
unii: 495W7451VQ
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINOhm Laboratories, Inc.7076e42a-17ff-4c42-9963-2dc02c0a5e492026-02-12WarningsExact identifier
unii: 495W7451VQ
FOSTER AND THRIVE ALLERGY AND CONGESTION DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC945fcda4-0dd8-43cf-a5dd-ecea7995330a2026-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
unii: 495W7451VQ
equate sinus 12 hourPSEUDOEPHEDRINE HYDROCHLORIDEWal-Mart Stores Incde65b99e-85e9-46c1-88b2-727c7ed8882a2026-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions511a5d9b-16a6-481c-a3d3-bcba911ecc9d2026-02-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER 7000054a59e95-f95a-4bcd-ac9d-8d4ace85277f2026-02-10WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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