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 16 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)6d454e89-59ce-40dc-b0d2-3330a7df519f2026-04-15WarningsExact identifier
unii: 495W7451VQ
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRVESPYR BRANDS LLC1c8fbf40-17c1-4ee9-a2b9-ca4a08e082932026-04-13WarningsExact identifier
unii: 495W7451VQ
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINVESPYR BRANDS LLCe2e3c628-d241-42b6-8c1e-ef997ffa6e872026-04-13WarningsExact identifier
unii: 495W7451VQ
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
mucus dGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company5065f07d-2130-4c84-a64a-dc27ef9cb92e2026-04-09WarningsExact identifier
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Mucus Relief DM CoughDEXTROMETHORPHAN HBR AND GUAIFENESINL.N.K. International, Inc.2fea3533-8218-4875-affe-5b33a22c553a2026-04-08WarningsExact identifier
unii: 495W7451VQ
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
unii: 495W7451VQ
Dr. Simi Mucus ReliefGUAIFENESINFarmacias De Similares TX LLC4ef7dae3-9081-bc3b-e063-6294a90a9a752026-04-08WarningsExact identifier
unii: 495W7451VQ
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leaderca735722-0baa-4c85-8311-17dbce915fc52026-04-08WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
unii: 495W7451VQ
ZYRTEC-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCf1ecf9ba-1c03-7fb7-e053-2a95a90a875a2026-04-06WarningsExact identifier
unii: 6V9V2RYJ8N
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company6aaed3fe-ce35-4533-aea4-80096ce8e57a2026-04-02WarningsExact identifier
unii: 495W7451VQ
nasal and chest decongestantGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc657aeccc-4f6a-496b-9a69-e64a81e4c91e2026-04-02WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Incc0f389ec-a683-4555-8892-896b3165952a2026-04-01WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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