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 63 of 110 · 2,187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
unii: 495W7451VQ
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
unii: 495W7451VQ
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
unii: 495W7451VQ
Bestmade Natural Products SiliceaSILICEABestmade Natural Productse9eadb4e-659b-dcae-e053-2995a90a0db72025-03-21WarningsExact identifier
unii: ETJ7Z6XBU4
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
unii: 495W7451VQ
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
unii: 495W7451VQ
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
unii: 495W7451VQ
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
unii: 495W7451VQ
Natural Eyes Stye Relief Fast Dissolving TablesAPIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEATRP Company30a5435b-32b0-807d-e063-6294a90a84da2025-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA HISPANA, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.00a2c1c7-2c04-4c71-9276-24ba87288d612025-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
Baby Nighttime Oral Pain ReliefARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDEHyland' Inc.58ef86b7-5b38-1591-e053-2991aa0aa53e2025-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus ReliefGUAIFENESINH E Befebda97-5234-451c-a854-91a32303a6b72025-03-17WarningsExact identifier
unii: 495W7451VQ
Bestmade Natural Products Tooth Remineralization RemedyCALCAREA PHOSPHORICA, CALCAREA FLUORICA, SILICEABestmade Natural Products304ca377-573a-6622-e063-6394a90a3fcc2025-03-14WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO18 Lactose FreeCALC FLUOR, SILICEA, CALC SULPHBestmade Natural Products3038634b-ae79-fe22-e063-6294a90a438e2025-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO25 Lactose FreeNAT PHOS, NAT SULPH, SILICEABestmade Natural Products303acd47-e033-1563-e063-6394a90ae38e2025-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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