H E B MAX SEVERE CONGESTION and COUGH

Product NDC
37808-317
11-digit product format
378080317
Labeler code
37808
Product ID
37808-317_9f2c6806-1156-4c91-8581-68b7fcf039ec
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-14
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 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
H E B MAX SEVERE CONGESTION and COUGH
Brand name suffix
Maxium Strength
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
1043543Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2b016ee-5329-45bf-9d71-d626204169cfAvailable 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
37808-317-25H E B MAX SEVERE CONGESTION and COUGHMaxium Strength177 mL in 1 BOTTLELIQUID1774

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
GUAIFENESINACTIVE INGREDIENT495W7451VQH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
GUAIFENESINACTIVE MOIETY495W7451VQH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
SORBITOLINACTIVE INGREDIENT506T60A25RH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEH E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-317H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B]4Current NDC, Legacy NDC, 1 package rows20231230_d2b016ee-5329-45bf-9d71-d626204169cf.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNd2b016ee-5329-45bf-9d71-d626204169cf4
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDd2b016ee-5329-45bf-9d71-d626204169cf4
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYd2b016ee-5329-45bf-9d71-d626204169cf4
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYd2b016ee-5329-45bf-9d71-d626204169cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-317-2537808031725177 mL in 1 BOTTLE (37808-317-25) 177 ml2012-09-140000-00-00NoNoCurrent