FDA.reportPublic FDA data

NDC 49035-640 - Cold and Flu DayTime, NightTime Severe

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
49035-640
Package NDCs from labels
49035-640-40
Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2022-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Equate 44-640677 De-listedWal-Mart Stores Inc | LNK International, Inc.2022-05-19HUMAN OTC DRUG LABEL

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 197 of 358 · 7,152 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
unii: 362O9ITL9D
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
unii: 15FIX9V2JP
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: 04JA59TNSJ
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLA-S Medication Solutions2653e4fc-4f08-426d-a0a4-31d647c1de562025-07-18WarningsExact identifier
unii: 532B59J990
Dual ActionACETAMINOPHEN AND IBUPROFEN (NSAID) TABLETS, 250 MG/ 125 MGDr. Reddy's Laboratories Incc8a8a18a-6766-37a9-d0f0-f9380fb5b0e82025-07-18WarningsExact identifier
unii: 362O9ITL9D
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
unii: 362O9ITL9D
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
unii: 362O9ITL9D
COUGH AND CONGESTION EXTENDED RELEASEGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy, Inc.14254a0c-a843-6eec-e063-6394a90a72c52025-07-16WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Good Sense Mucus ERGUAIFENESINL. Perrigo Company30860399-d9a3-409b-bfac-00597c74b1752025-07-16WarningsExact identifier
unii: 495W7451VQ
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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