NDC 76095-010-01 - Cold Medicine XL3 FORTE

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
76095-010
Requested NDC
76095-010-01
Package NDCs from labels
76095-010-04, 76095-010-50, 76095-010-02, 76095-010-20, 76095-010-01, 76095-010-10
Manufacturer
MIDWAY IMPORTING INC. | Selder, S.A. de C.V.
Effective date
2024-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XL3FrteactmnphnchlrphnirmnphnylphrinhclMdwayMIDWAY IMPORTING INC. | Selder, S.A. de C.V.2024-10-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76095-010-01Cold MedicineXL3 FORTE10 in 1 BLISTER PACKTABLET107
76095-010-02Cold MedicineXL3 FORTE10 in 1 BLISTER PACKTABLET107
76095-010-04Cold MedicineXL3 FORTE4 in 1 PACKETTABLET47
76095-010-10Cold MedicineXL3 FORTE1 in 1 BOXTABLET17
76095-010-20Cold MedicineXL3 FORTE2 in 1 BOXTABLET27
76095-010-50Cold MedicineXL3 FORTE50 in 1 BOXTABLET507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76095-010COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING INC.]7Current NDC, Legacy NDC, 6 package rows20241027_58252f15-485c-3061-e053-2a91aa0a2320.zip

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 99 of 533 · 10,659 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
Ethyl AlcoholETHYL ALCOHOLUpLift Brands, LLC289d6e34-4d71-b24e-e063-6394a90ac26d2026-04-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3339d3bd-b416-4c5b-8984-0c376544d8a92026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsExact identifier
application number: M012
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAmici Pharma, Inc.fb12459c-82f8-43d2-8c05-a4b6d4a3e9482026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEPar Health USA, LLCd92631a6-bae8-493b-b4df-c563346607a82026-04-13Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
AllergyDIPHENHYDRAMINE HCLPublix Super Markets Incf2263e38-f686-45ed-bf85-b47f5e1aa9822026-04-13WarningsExact identifier
application number: M012
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLBETTER LIVING BRANDS, LLC46adbf94-5b93-ee64-e063-6294a90a11442026-04-11WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Pain Relief Dye freeACTEMINOPHENBETTER LIVING BRANDS LLC.41f504d1-29c4-f075-e063-6394a90ad64c2026-04-11WarningsExact identifier
unii: 362O9ITL9D
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Smart Care FRESH RAIN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.8f9e8021-877f-4888-94f9-9eee17fe2afb2026-04-10WarningsExact identifier
unii: 3K9958V90M
Tramadol/APAPTRAMADOL/APAPDirect_rx4e40f55e-1d8e-ce2f-e063-6294a90a7bec2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENMedline Industries, LP9f18d455-55ce-482c-8da8-dcb664038c6c2026-04-10WarningsExact identifier
unii: 362O9ITL9D
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
unii: 362O9ITL9D
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
unii: 04JA59TNSJ
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.28413cb3-22c4-40e2-ad6b-42beb438dea32026-04-10WarningsExact identifier
unii: 362O9ITL9D
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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