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 21 of 110 · 2,187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Incc0f389ec-a683-4555-8892-896b3165952a2026-04-01WarningsExact identifier
unii: 495W7451VQ
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
unii: 6V9V2RYJ8N
nasal decongestantPSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc06092347-33fe-46b8-829c-70e4ca15ecf22026-04-01WarningsExact identifier
unii: 6V9V2RYJ8N
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
unii: 495W7451VQ
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Companya5aa414c-a143-44c8-9759-e84c0f032fbf2026-04-01WarningsExact identifier
unii: 6V9V2RYJ8N
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsExact identifier
unii: 495W7451VQ
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
unii: 495W7451VQ
Dr Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCalmCo LLC3f156679-7a91-aff1-e063-6394a90a18f62026-03-31WarningsExact identifier
unii: 495W7451VQ
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINA-S Medication Solutionsc26da6e0-ab1c-46c2-acf5-0074958c03cd2026-03-31WarningsExact identifier
unii: 495W7451VQ
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: ETJ7Z6XBU4
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgGUAIFENESINTWIN MED LLCd9d13c67-51a1-aa79-e053-2995a90abdbb2026-03-26WarningsExact identifier
unii: 495W7451VQ
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
mucus erGUAIFENESINHyVee Inc851f49b5-34a0-4c58-90fa-51e265c7f7312026-03-26WarningsExact identifier
unii: 495W7451VQ
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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