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 98 of 107 · 2,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINWINCO FOODS, LLCf45f43da-b992-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Maximum StrengthGUAIFENESINWINCO FOODS, LLCf45f43da-b955-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLCaf359aca-ec58-47cb-843a-2def1a09a09a2023-04-10WarningsExact identifier
unii: 495W7451VQ
Crcle Guaifenesin Extended-Release Tablets, 600 mgGUAIFENESIN EXTENDED-RELEASEInnovus Pharmaceuticals, Inc.bba4b91a-bea9-41be-9588-5fb1483c7d102023-04-08WarningsExact identifier
unii: 495W7451VQ
DG Health Mucus ERGUAIFENESINDolgencorp, LLCbf99fa83-c3be-4052-b5b6-ad91997cb0342023-04-06WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMGUAIFENESIN, DEXTROMETHORPHAN HBRStrategic Sourcing Services LLC5eb5f84f-4cb8-4552-b73d-c2b27657fa152023-04-06WarningsExact identifier
unii: 495W7451VQ
GUAIFENESINGUAIFENESINSafrel Pharmaceuticals, LLC.e2a3d6cb-5251-b88e-e053-2a95a90a9e302023-03-28WarningsExact identifier
unii: 495W7451VQ
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
Betr remedies chest congestion reliefGUAIFENESINLive Betr LLC638390ce-4a25-459c-a475-12e079a1d67f2023-03-20WarningsExact identifier
unii: 495W7451VQ
Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.4226f394-f85e-45b1-8d5f-7cffb7dd492f2023-03-16WarningsExact identifier
unii: 495W7451VQ
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
GUAIFENESIN - ODAAT 1200 MGGUAIFENESINLODAAT LLCf61d3ae0-11eb-2a82-e053-2995a90a95da2023-03-04WarningsExact identifier
unii: 495W7451VQ
Betr chest congestion reliefGUAIFENESINLive Betr LLCadd40484-8e77-464b-939c-a3c620b993cb2023-02-22WarningsExact identifier
unii: 495W7451VQ
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
mucusGUAIFENESINCVS Pharmacyd6f1889e-8228-4c8c-a0e9-6c2afdc07e992023-01-25WarningsExact identifier
unii: 495W7451VQ
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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