FDA.reportPublic FDA data

Cold, Flu and Sore Throat

Product NDC
53942-516
11-digit product format
539420516
Labeler code
53942
Product ID
53942-516_b505e146-c5c6-4f36-8cbb-cb08c0940bcc
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-19
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Listing certified through
2027-12-31
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
Cold, Flu and Sore Throat
Brand name suffix
Maxium Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116572Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d98029c0-ccd9-47e1-996f-c7786cd4eccaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-516-25Cold, Flu and Sore ThroatMaxium Strength177 mL in 1 BOTTLELIQUID1773

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GUAIFENESINACTIVE MOIETY495W7451VQCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92COLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-516COLD, FLU AND SORE THROAT MAXIUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [DEMOULAS MARKET BASKET]3Current NDC, Legacy NDC, 1 package rows20231230_d98029c0-ccd9-47e1-996f-c7786cd4ecca.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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACKACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLWAL-MART STORES INC888bd90a-a059-4814-bd65-6b735ecfaf3a2026-08-31WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime and NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger49a98411-aa5a-6de3-e063-6294a90a148f2026-08-31WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDESixarp, LLC5a5a6917-9fb5-e6ca-e063-6394a90af9dc2026-08-31WarningsExact identifier
application number: M012
Zicam Intense Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.d916f7ff-84b7-57ef-e053-2995a90a3efa2026-08-31WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-31WarningsExact identifier
application number: M012
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLSixarp, LLC5a5e2458-bab0-4931-e063-6394a90ad6062026-08-31WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
application number: M012
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
application number: M012
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNd98029c0-ccd9-47e1-996f-c7786cd4ecca3
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDd98029c0-ccd9-47e1-996f-c7786cd4ecca3
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYd98029c0-ccd9-47e1-996f-c7786cd4ecca3
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYd98029c0-ccd9-47e1-996f-c7786cd4ecca3
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYd98029c0-ccd9-47e1-996f-c7786cd4ecca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-516-2553942051625177 mL in 1 BOTTLE (53942-516-25) 177 ml2013-09-190000-00-00NoNoCurrent