FDA.reportPublic FDA data

NDC 70677-1011-01 - 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
70677-1011
Requested NDC
70677-1011-01
Package NDCs from labels
70677-1011-1, 70677-1011-01
Manufacturer
Strategic Sourcing Services, LLC | Dr. Reddys Laboratories Limited (SEZ UNIT)
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsStrategic Sourcing Services, LLC | Dr. Reddys Laboratories Limited (SEZ UNIT)2025-12-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1011-1Guaifenesin and Pseudoephedrine HCl18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE182
70677-1011-1Guaifenesin and Pseudoephedrine HCl1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1011GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC]1Current NDC, 2 package rows20230422_51ec068b-e219-381a-384b-a208a306d5ba.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1011-1EA - Each70677-1011bd89b2fc-309f-405e-a0cd-fa8f42249b2412023-09-05

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 48 of 110 · 2,187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
unii: 495W7451VQ
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRAurohealth LLCd0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b72025-11-13WarningsExact identifier
unii: 495W7451VQ
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
BONE HPSODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT.Natural Creations, Inc.93d2b385-9ce3-4d16-b428-1638e9a55f922025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
unii: 495W7451VQ
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
unii: 495W7451VQ
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
unii: 495W7451VQ
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
unii: 495W7451VQ
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
unii: 495W7451VQ
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
unii: 495W7451VQ
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
unii: 495W7451VQ
TUSSI PRES PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVISb01a45df-3cea-4729-80c1-7f35b7f707f02025-11-12WarningsExact identifier
unii: 495W7451VQ
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
unii: 495W7451VQ
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)32f58b4a-3e1b-424f-8296-a9bf9a7d70252025-11-11WarningsExact identifier
unii: 495W7451VQ
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
unii: 495W7451VQ
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
unii: 495W7451VQ
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2426bf76-19bf-4bfd-8f9e-3b348e4b56412025-11-11WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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