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 10 of 77 · 1,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex Maximum StrengthGUAIFENESINReckitt Benckiser LLC47f5323c-ee3a-400d-b133-31d9c286fafd2026-05-27WarningsExact identifier
unii: 495W7451VQ
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
rxcui: 1305603
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
unii: 495W7451VQ
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
unii: 495W7451VQ
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
unii: 495W7451VQ
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
unii: 495W7451VQ
Leader Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader12971fb2-2314-4443-bf70-b7eb5859b1482026-05-26WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
equate mucus reliefGUAIFENESINWALMART INC.154602ca-91c4-4030-ae77-9bf179cc95e82026-05-26WarningsExact identifier
unii: 495W7451VQ
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsc04e67da-51f6-4ce3-9852-419d7b3a37422026-05-22WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
unii: 495W7451VQ
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
unii: 495W7451VQ
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
unii: 495W7451VQ
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
unii: 495W7451VQ
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
unii: 495W7451VQ
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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