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 100 of 107 · 2,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defend Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.bb851be1-0528-4199-91e7-e09f994b28622022-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Relief Extended Release Maximum StrengthGUAIFENESINH E B6f075c29-8256-4cac-96c4-a772a53ad21d2022-12-09WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRPUBLIX SUPER MARKETS, INC9870b7ee-2bfb-42f5-9762-77d2dd13434a2022-12-06WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan Hydrobromide HBRGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDERITE-AID2343f031-d658-498a-b5d1-6dcdb26b3cf02022-12-06WarningsExact identifier
unii: 495W7451VQ
Guaifenesin and Dextromethorphan HBrGUAIFENESIN AND DEXTROMETHORPHAN HBRSUN PHARMACEUTICAL INDUSTRIES, INC.06328741-03e3-49cf-ae44-d4c2116e38a32022-12-06WarningsExact identifier
unii: 495W7451VQ
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAOHM PHARMA INC.044a7174-f7a3-490f-9cad-01f2665d75752022-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
MAXIMUM STRENGTH Mucus DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy9a560b80-972c-4af5-8fe8-eaef0b0d83b32022-12-01WarningsExact identifier
rxcui: 1244675
unii: 6V9V2RYJ8N
unii: 495W7451VQ
GUAIFENESINGUAIFENESINCVS4efa8bf9-3394-47b4-b630-9476b15d2dfc2022-11-23WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Extended ReleaseGUAIFENESINCare One (American Sales Company)96569c70-0936-4041-ab32-2b2262402f342022-11-21WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthGUAIFENESINCare One (American Sales Company)c94e3943-20da-4bd4-b0ff-6aa60b03a1bf2022-11-21WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINMcKesson Corporation dba SKY Packaging69b61f05-8f0b-420f-b4ef-df933b70eebc2022-11-21WarningsExact identifier
unii: 495W7451VQ
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
DG health mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLCadd72ca5-94cd-437f-b30f-6149c08b5f212022-11-14WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINH E B562b6ab6-4795-4909-8008-e919173844c92022-11-07WarningsExact identifier
unii: 495W7451VQ
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAmerisource Bergen8d397f4f-ac5e-426d-a26b-ee064b6e50282022-11-04WarningsExact identifier
unii: 6V9V2RYJ8N
Pseudoephedrine HClPSEUDOEPHEDRINE HCLAurohealth LLC1056d9da-8a3f-4b7a-878e-7f8d45d298cd2022-11-03WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)eb3ef974-4e79-4065-a8c9-9307092da6b32022-10-21WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRCare One (Retail Business Services, LLC.)93658f3c-1f57-41b5-acdc-ee7ee47656a32022-10-21WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Extended Release CapletsGUAIFENESIN, DEXTROMETHORPHAN HBRCardinal Health (Leader) 7000004af43e6-6276-42ec-a902-3de22bc9fdea2022-10-20WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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