Equate Severe Cold Multi Symptom

Product NDC
49035-907
11-digit product format
490350907
Labeler code
49035
Product ID
49035-907_5bb327e2-5195-2d1c-e063-6394a90a5dff
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-18
Marketing end
2027-08-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Equate Severe Cold Multi Symptom

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-907-91Equate Severe Cold Multi Symptom6 in 1 CARTONPOWDER, FOR SOLUTION68
49035-907-91Equate Severe Cold Multi Symptom1 in 1 PACKETPOWDER, FOR SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-907EQUATE SEVERE COLD MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [WAL-MART STORES INC]7Current NDC, Legacy NDC, 2 package rows20241105_ebe0dc20-f7b2-4e3c-bce8-248085153869.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 132 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.82813342-2be2-4731-ae90-dbd5eed667a92024-12-10WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.b640a5d2-a7fe-486d-a65f-e7c993f950d62024-12-10WarningsExact identifier
application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat DropsMENTHOLRicola USA Inc.c3f3c062-55e5-43c1-a016-ee47a7b388a52024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola USA Inc.ee4733b5-6e5a-438a-97da-110f3ef6c8092024-12-10WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola USA Inc.f62fcc38-2d43-40b3-841f-c8eea9ebd1e12024-12-10WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.8a6db093-7e52-443f-8dd6-94867606fef82024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola USA Inc.5885343e-4a6e-44f7-87a4-d525991561972024-12-10WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola USA Inc.0baf383c-886d-47ca-8a6d-221298c794462024-12-10WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEBest Choice (Valu Merchandisers Company)539b8972-2a46-468e-ad27-6672d746feb72024-12-10WarningsExact identifier
application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
application number: M012
Adult Allergy ReliefCALMCO ALLERGY RELIEFCalmCo08288825-0f38-b6a3-e063-6394a90aa3582024-12-07WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola Agc142663f-086e-4ab7-a758-9107d70775372024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag984c9793-163c-4b97-b244-9b471966a1222024-12-05WarningsExact identifier
application number: M012
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
application number: M012
Cold Multi Symptom Daytime NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Associationd5cbb5b0-564c-429e-b680-fa683e7963932024-12-05WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCarede8a623f-7b10-4d56-a74b-3737e7716ffe2024-12-05WarningsExact identifier
application number: M012
Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC9773958b-c5e5-4da7-a8e9-6b6c223a2b302024-12-05WarningsExact identifier
application number: M012
Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC399e0e51-c2a7-451c-b74d-d3db140cef692024-12-05WarningsExact identifier
application number: M012
Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI09531edc-8dbd-451f-ae02-f922e9e8c2482024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag71ca8af7-172d-40da-be1e-ff3ab5568e742024-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNebe0dc20-f7b2-4e3c-bce8-2480851538698
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDebe0dc20-f7b2-4e3c-bce8-2480851538698
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYebe0dc20-f7b2-4e3c-bce8-2480851538698
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYebe0dc20-f7b2-4e3c-bce8-2480851538698
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYebe0dc20-f7b2-4e3c-bce8-2480851538698

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-907-91490350907916 PACKET in 1 CARTON (49035-907-91) / 1 POWDER, FOR SOLUTION in 1 PACKET6 packet2016-07-182027-08-31NoNoCurrent