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 43 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRKROGER COMPANY15e54152-dc82-6442-e063-6294a90a85412025-07-16WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRKROGER COMPANY15b98b7d-2274-450d-e063-6394a90a8d1d2025-07-16WarningsExact identifier
unii: 495W7451VQ
MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASEGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.13ee8bb1-9525-a5bc-e063-6294a90a9db92025-07-16WarningsExact identifier
unii: 495W7451VQ
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
unii: 495W7451VQ
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
unii: 495W7451VQ
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
unii: 6V9V2RYJ8N
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
ACTINEL PEDIATRICDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLC6bb92d74-4893-40b8-af58-eb307155e8762025-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC847014ab-86ae-40c5-8e7f-f1ddea14f1b32025-07-08WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus ReliefGUAIFENESIN 400 MGCabinet Health, Inc.26a51b0e-039c-663c-e063-6394a90ad3842025-07-07WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC8188b66a-5405-4e62-bde6-63ebc1f22b162025-07-04WarningsExact identifier
unii: 495W7451VQ
basic care mucus er maxGUAIFENESINAmazon.com Services LLC3552346e-4650-44c1-9233-57251a0291332025-07-02WarningsExact identifier
unii: 495W7451VQ
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limitedb109249a-a0be-41bd-b6ce-ef621b588ddc2025-07-02WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINAdvanced Rx LLCcb7cd1df-8cfb-4a9c-9567-809a2343622e2025-07-01WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Maximum StrengthGUAIFENESIN, DEXTROMETHORPHAN HBRChain Drug Consortium, LLCd6aae1a1-0ab9-4b26-9f62-b8761014bb352025-06-30WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRATLANTIC BIOLOGICALS CORP.308f50dd-e8d6-0264-e063-6394a90afa682025-06-27WarningsExact identifier
unii: 495W7451VQ
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
unii: 495W7451VQ
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c92025-06-23WarningsExact identifier
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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