FDA.reportPublic FDA data

NDC 70677-1010-01 - Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

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
70677-1010
Requested NDC
70677-1010-01
Package NDCs from labels
70677-1010-1, 70677-1010-01
Manufacturer
Strategic Sourcing Services, LLC
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
FEXOFENADINE HYDROCHLORIDE - Strategic Sourcing Services, LLCStrategic Sourcing Services, LLC2025-12-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1010-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride4 in 1 CARTONTABLET, EXTENDED RELEASE42
70677-1010-1Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1010FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC]1Current NDC, 2 package rows20230422_23fdb518-8dcc-3671-f116-ea8c7b0a6e08.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1010-1EA - Each70677-101057c6b6ac-e972-482c-b88e-65235fb4bdbb12023-09-05

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 23 of 59 · 1,169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation82654829-a2a5-06aa-930c-5bdd60e49b102025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWalgreens Company01047716-389b-df25-ebe6-c897fc47d3df2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLRite Aid Corporation9fb0c938-d24b-2371-95db-6c82d9511d722025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLStrategic Sourcing Services, LLC51ec068b-e219-381a-384b-a208a306d5ba2025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Mucus DGUAIFENESIN 600 MG AND PSEUDOEPHEDRINE HCL 60 MGCVS Health Corp284bbf6a-8b34-09b6-3115-553a9ec831222025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services, LLC23fdb518-8dcc-3671-f116-ea8c7b0a6e082025-12-10WarningsExact identifier
application number: ANDA215434
ndc (package): 70677-1010-1
ndc (product): 70677-1010
ndc11 (package): 70677101001
rxcui: 997406
spl id: c604326c-44ff-2c88-4d4f-d5279566bf8d
spl set id: 23fdb518-8dcc-3671-f116-ea8c7b0a6e08
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLWalgreens Company2619b68b-835a-c7f2-ecbc-39944d5ba8a52025-12-10WarningsExact identifier
unii: 6V9V2RYJ8N
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Health Corpb009e6b1-57da-a002-1a9e-38a96cc041f12025-12-10WarningsExact identifier
application number: ANDA215434
rxcui: 997406
unii: 2S068B75ZU
unii: 6V9V2RYJ8N
Secale QuartzSECALE QUARTZUriel Pharmacy Inc.1e9f55d7-22d5-4412-ac35-b4400bdf29a02025-12-08WarningsExact identifier
unii: ETJ7Z6XBU4
Aleve-D Sinus and HeadacheNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDEBayer HealthCare LLC.5ab980c0-c48a-233b-e053-2991aa0a4fd12025-12-04WarningsExact identifier
unii: 6V9V2RYJ8N
Aleve-D Sinus and ColdNAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDEBayer HealthCare LLC.599ea6c8-03ad-536e-e053-2991aa0a83a32025-12-04WarningsExact identifier
unii: 6V9V2RYJ8N
Capmist DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECapital Pharmaceutical, LLC63733ac3-859e-4a8e-8717-d852bd3034082025-12-03WarningsExact identifier
unii: 6V9V2RYJ8N
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPa1e80757-346f-4d88-8da7-55583c3a902b2025-11-26WarningsExact identifier
unii: 2S068B75ZU
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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