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 72 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLCVS Pharmacy, Inc.b8a4d9be-e202-4f99-bece-e2125aaca8b92023-07-14WarningsExact identifier
unii: 6V9V2RYJ8N
Leader Allergy Relief DCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader3152060c-f613-49db-91d4-356d2070c4662023-06-15WarningsExact identifier
unii: 6V9V2RYJ8N
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions440d0554-995c-47df-b9f6-f3e3ce2e35e02023-06-06Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAARNA USA, Inc.6e488782-0138-436d-a9f0-0ec5bc9daedd2023-05-15WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)ee34af0f-61ba-49fa-81e0-20da4c5823682023-05-03WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINFSA STORE INC.f524479a-2c15-50d9-e053-2995a90a805e2023-05-03WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC3578086b-f961-4494-9bbd-5305320487272023-04-21WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINWINCO FOODS, LLCf45f43da-b992-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthGUAIFENESINWINCO FOODS, LLCf45f43da-b955-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLCaf359aca-ec58-47cb-843a-2def1a09a09a2023-04-10WarningsExact identifier
unii: 495W7451VQ
Crcle Guaifenesin Extended-Release Tablets, 600 mgGUAIFENESIN EXTENDED-RELEASEInnovus Pharmaceuticals, Inc.bba4b91a-bea9-41be-9588-5fb1483c7d102023-04-08WarningsExact identifier
unii: 495W7451VQ
DG Health Mucus ERGUAIFENESINDolgencorp, LLCbf99fa83-c3be-4052-b5b6-ad91997cb0342023-04-06WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLC5eb5f84f-4cb8-4552-b73d-c2b27657fa152023-04-06WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINSafrel Pharmaceuticals, LLC.e2a3d6cb-5251-b88e-e053-2a95a90a9e302023-03-28WarningsExact identifier
unii: 495W7451VQ
Betr remedies chest congestion reliefGUAIFENESINLive Betr LLC638390ce-4a25-459c-a475-12e079a1d67f2023-03-20WarningsExact identifier
unii: 495W7451VQ
Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.4226f394-f85e-45b1-8d5f-7cffb7dd492f2023-03-16WarningsExact identifier
unii: 495W7451VQ
GUAIFENESIN - ODAAT 1200 MGGUAIFENESINLODAAT LLCf61d3ae0-11eb-2a82-e053-2995a90a95da2023-03-04WarningsExact identifier
unii: 495W7451VQ
Betr chest congestion reliefGUAIFENESINLive Betr LLCadd40484-8e77-464b-939c-a3c620b993cb2023-02-22WarningsExact identifier
unii: 495W7451VQ
mucusGUAIFENESINCVS Pharmacyd6f1889e-8228-4c8c-a0e9-6c2afdc07e992023-01-25WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2023-01-17WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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