FDA.reportPublic FDA data

NDC 79481-1002-01 - Guaifenesin and Pseudoephedrine HCl

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
79481-1002
Requested NDC
79481-1002-01
Package NDCs from labels
79481-1002-1, 79481-1002-01
Manufacturer
Meijer | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GUAIFENESIN - Meijer | Aurohealth LLC | APL HEALTHCARE LIMITEDMeijer | Aurohealth LLC | APL HEALTHCARE LIMITED2023-12-01Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-1002-1Guaifenesin and Pseudoephedrine HCl18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE183
79481-1002-1Guaifenesin and Pseudoephedrine HCl1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-1002GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [MEIJER]3Current NDC, Legacy NDC, 2 package rows20231202_c051be4b-88c9-e56f-e053-2995a90a3aa8.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 93 of 106 · 2,106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c31d465-caac-3a02-e053-2a95a90adb3b2023-11-03WarningsExact identifier
unii: ETJ7Z6XBU4
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
unii: 495W7451VQ
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
unii: 495W7451VQ
Thymus SarcodeECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUSNutritional Specialties, Inc.2dfda48f-5795-4b98-8bb2-bf65273e89202023-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect hangover reliefALUMINA SILICATA, CALCAREA SILICATA, SILICEA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, FERRUM MURIATICUM, SULPHUR, PHOSPHORUSKadesh Incoporation Co,Ltdc9821e87-1e8d-48ab-8821-32e7e660309a2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect first aid antiseptic and antibiotic solutionSILICEA, SULPHUR, PHOSPHORUS, CALCAREA SILICATA, NATRUM NITRICUM, FERRUM MURIATICUM, KALI SILICATUMKadesh Incoporation Co,Ltd9bd266bb-7078-413f-8fc9-6423535891302023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect cold remedyCALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUMKadesh Incoporation Co,Ltd14d2a1fe-a1f1-4e85-96c0-d8b90260336c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLA-S Medication Solutions204849d1-ac4b-4dbe-8769-fcb30291f8802023-10-31WarningsExact identifier
unii: 6V9V2RYJ8N
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
unii: 495W7451VQ
Mucosa GuifenesinGUAIFENESINMagno-Humphries, Inc.9d22c208-d0ae-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
unii: 495W7451VQ
MUCINEXGUAIFENESINA-S Medication Solutions08ea92cc-4a0f-44c9-9edf-71f67e0144312023-10-23WarningsExact identifier
unii: 495W7451VQ
ROBAFEN DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutionsd5965f49-2b89-425c-9909-c75c87f930fc2023-10-22WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
unii: 495W7451VQ
Mucinex DM, TRAVEL BASIXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.c274b05c-8f05-4980-9a93-77affb322e572023-10-10WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
unii: 495W7451VQ
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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