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 18 of 106 · 2,106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INCf2eb5494-2672-444f-afa3-d1ef8ed1eaa12026-04-22WarningsExact identifier
unii: 495W7451VQ
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
unii: 6V9V2RYJ8N
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
unii: 495W7451VQ
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
unii: 495W7451VQ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
unii: 495W7451VQ
Mucinex D Maximum StrengthGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd9264518-2f2c-498f-b733-6f3397336a012026-04-21WarningsExact identifier
unii: 6V9V2RYJ8N
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INCdd00dfc0-e523-4dec-8fc0-50363eadec572026-04-20WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBROHM LABORATORIES INC07b9854d-1ec6-4c8a-983e-96ed1e2de1c22026-04-20WarningsExact identifier
unii: 495W7451VQ
good sense mucus erGUAIFENESINRedpharm Drug4fb57f87-f761-b52e-e063-6294a90ae4ee2026-04-18WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
unii: 495W7451VQ
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
unii: 495W7451VQ
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
unii: 495W7451VQ
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
unii: 495W7451VQ
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINBest Choice (Valu Merchandisers Company)9bac4bbb-a20c-48c5-891b-63f14a664d042026-04-15WarningsExact identifier
unii: 495W7451VQ
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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