FDA.reportPublic FDA data

NDC 70518-4526-01 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

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
70518-4526
Requested NDC
70518-4526-01
Package NDCs from labels
70518-4526-1, 70518-4526-0, 70518-4526-3, 70518-4526-2, 70518-4526-5, 70518-4526-4, 70518-4526-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALCOHOL - REMEDYREPACK INC.REMEDYREPACK INC.2026-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4526-0Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide3 in 1 BOXSYRUP34
70518-4526-1Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide20 mL in 1 CUPSYRUP204
70518-4526-2Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide6 in 1 BOXSYRUP64
70518-4526-3Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide10 mL in 1 CUPSYRUP104
70518-4526-4Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide12 in 1 BOXSYRUP124
70518-4526-5Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide5 mL in 1 CUPSYRUP54

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 54 of 272 · 5,432 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Scriptsusa Hand SanitizerALCOHOLEnergized Solution Corp4f97edd9-717a-315b-e063-6394a90aade72026-04-27WarningsExact identifier
unii: 3K9958V90M
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
unii: 9D2RTI9KYH
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
unii: 3K9958V90M
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLMerchSource, LLC5054a055-50d0-f12a-e063-6294a90ad78e2026-04-25WarningsExact identifier
unii: 3K9958V90M
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
unii: 9D2RTI9KYH
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Ethyl AlcoholETHYL ALCOHOLUpLift Brands, LLC5035ec52-2d65-cbbf-e063-6294a90a4a5c2026-04-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
unii: 9D2RTI9KYH
Foaming Sanitizing HandALCOHOLKutol Products Companyb2e22e51-88f5-4391-8705-3855c1645d802026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Amber Breeze ScentedALCOHOLFourstar Group USA, Inc.eb39678d-7576-4147-be02-b7779a5758282026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Kick Off ScentedALCOHOLFourstar Group USA, Inc.860f25c3-54b0-4438-ba97-0fc81cf350442026-04-24WarningsExact identifier
unii: 3K9958V90M
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
unii: 9D2RTI9KYH
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAtlantic Biologicals Corp.5022379d-05ef-63f2-e063-6294a90a21892026-04-23Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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