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 37 of 540 · 10,784 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ashley Belle Moisturizing Hand Sanitizer Amber GlowALCOHOLMy Imports USA LLC6cc64f29-1ad4-4ab9-aeff-e0966f27c48e2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer PumpkinALCOHOLMy Imports USA LLC53ee6f2f-b898-4b0b-bc29-7757e9a1f2482026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Pistachio GlowALCOHOLMy Imports USA LLCa4e84f2f-b389-4ba7-9e18-33bd9b07825e2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Matcha MistALCOHOLMy Imports USA LLC1cd01693-ef98-406e-af3a-499900d16d832026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Autumn Berry CrumbleALCOHOLMy Imports USA LLC42648f20-8666-4fdd-964d-8961ee71b4952026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer White Tea BlossomALCOHOLMy Imports USA LLC7ab834ef-a2f2-410a-92af-fb2cbcf845a32026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Aloe Cucumber MistALCOHOLMy Imports USA LLCabba3e7f-e79f-4c37-91dd-9e9aaf0a97f52026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sea Salt AirALCOHOLMy Imports USA LLCcbecb4d1-d00a-439f-9d10-910b47c216ca2026-07-15WarningsExact identifier
unii: 3K9958V90M
Spectrum Hand Sanitizer WipesETHYL ALCOHOLMedline Industries, LP8642a2b5-b34e-5bbd-e053-2991aa0a55a02026-07-15WarningsExact identifier
unii: 3K9958V90M
Quality Choice Effervescent Cold Relief - PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93fe6d-ee21-e323-e063-6394a90a61bf2026-07-15WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93c815-63c7-bfe0-e063-6394a90ab4a52026-07-15WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.568f791d-d6c3-7092-e063-6294a90a4b522026-07-14WarningsExact identifier
unii: 3K9958V90M
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leader0fad61d8-4393-47ec-9ff6-7df5be761f5b2026-07-14WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
application number: M012
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
GOOD NEIGHBOR PHARMACY Childrens Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGENc499574c-f32b-4608-bf8b-51ad44e357252026-07-13WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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