FDA.reportPublic FDA data

Head Congestion plus Flu Severe

Product NDC
37808-574
11-digit product format
378080574
Labeler code
37808
Product ID
37808-574_25007d2b-6980-8031-e063-6394a90a5efe
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HEB
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-14
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1
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
2026-12-31
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
Head Congestion plus Flu Severe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN100 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

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
1098435Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb7920a3-3c25-6aa1-e053-2995a90ac2b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-574-02Head Congestion plus Flu Severe12 in 1 BLISTER PACKTABLET, COATED123
37808-574-02Head Congestion plus Flu Severe2 in 1 CARTONTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-574HEAD CONGESTION PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]3Current NDC, 2 package rows20241023_eb7920a3-3c25-6aa1-e053-2995a90ac2b9.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 129 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSNeb7920a3-3c25-6aa1-e053-2995a90ac2b93
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDeb7920a3-3c25-6aa1-e053-2995a90ac2b93
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYeb7920a3-3c25-6aa1-e053-2995a90ac2b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-574-02378080574022 BLISTER PACK in 1 CARTON (37808-574-02) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2023-04-14NoNoCurrent