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 38 of 536 · 10,706 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good NeighborChildrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLAMERISOURCE BERGENf442c61b-7d2c-401c-b862-acbe2282927b2026-07-13WarningsExact identifier
application number: M012
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb528515a-ca0e-4184-b732-07fae3b380a52026-07-13WarningsExact identifier
unii: 3K9958V90M
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
application number: M012
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f4a507-df3f-e265-e063-6294a90acd112026-07-13WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f81b63-2b08-77b1-e063-6294a90afeba2026-07-13WarningsExact identifier
unii: 3K9958V90M
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited7171f607-90cc-4750-9928-20792ac2eaa22026-07-13WarningsExact identifier
unii: 3K9958V90M
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINAMERISOURCE BERGEN0269c0fd-0d8f-4264-9025-d4dcb3c45c602026-07-13WarningsExact identifier
application number: M012
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
application number: M012
Sinus Pressure and Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLRite Aid Corporation35bcf263-3296-4d9c-84c0-146a173d6e872026-07-13WarningsExact identifier
application number: M012
Good Neighbor Childrens Cough Relief Cherry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGENa8e2fd43-b801-41ae-8d79-8ecf4a7715432026-07-13WarningsExact identifier
application number: M012
Good Neighbor No Drip Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGEN7872aadd-b23c-431f-8048-24eece25ca2d2026-07-13WarningsExact identifier
application number: M012
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3417a685-544b-4dd0-b3e9-b5c463a679b62026-07-13WarningsExact identifier
unii: 3K9958V90M
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack8a4cf981-37f7-4bc9-a9d7-b134a5fd08942026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited91d4c729-ebbe-45db-a4cd-dbf6bd542a292026-07-13WarningsExact identifier
unii: 3K9958V90M
Good Neighbor Dye Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGEN404a3521-8340-4476-a068-0e69cd0e514f2026-07-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
unii: 362O9ITL9D
Good Neighbor Long Acting Cough Adult TussinDEXTROMETHORPHAN HBRAMERISOURCE BERGENdf3c76bd-bd5b-42d7-a5f1-560fd3cba6462026-07-13WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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