FDA.reportPublic FDA data

daytime severe cold and flu

Product NDC
37808-603
11-digit product format
378080603
Labeler code
37808
Product ID
37808-603_d95ea6e4-b9ad-47ac-ab11-96cf09762808
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-11
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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
daytime severe cold and flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN200 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

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
1369842Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec0b5f4b-b58c-445f-acf1-c7ce301bba64Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-603-40daytime severe cold and flu355 mL in 1 BOTTLESOLUTION3558

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-603DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [H E B]7Current NDC, Legacy NDC, 1 package rows20241030_ec0b5f4b-b58c-445f-acf1-c7ce301bba64.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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
application number: M012
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLSportpharm LLC7f4e8d37-8c6b-4849-b86c-4335a0bcac1c2026-03-06WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLBetter Living Brands, LLC0153294d-7f52-4d92-8db8-daeca3e29a3b2026-03-06WarningsExact identifier
application number: M012
Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution, Inc.87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e2026-03-06WarningsExact identifier
application number: M012
RYNEX PEBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLEDWARDS PHARMACEUTICALS, INC.77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef2026-03-05WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)042f9449-4af0-4b15-bb3e-236afeb1e11f2026-03-05WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGNUVICARE LLC6c4bc7d1-09d9-4311-8457-a1d47ab02a5a2026-03-05WarningsExact identifier
application number: M012
Allergy Relief childrensDIPHENHYDRAMINE HCLWALMART INC.dceb99a9-4aa3-4acc-b632-9a4ba8c879192026-03-04WarningsExact identifier
application number: M012
AMAZON Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMAZON.COM SERVICES LLC26101105-a6cf-4b51-a639-9d078542fea32026-03-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLMajor Pharmaceuticals3a976e90-c6af-4414-984e-9987158c9e982026-03-04WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)714e93ec-0aa9-4be2-9311-399e82f148e02026-03-04WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNec0b5f4b-b58c-445f-acf1-c7ce301bba648
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDec0b5f4b-b58c-445f-acf1-c7ce301bba648
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYec0b5f4b-b58c-445f-acf1-c7ce301bba648
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYec0b5f4b-b58c-445f-acf1-c7ce301bba648
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYec0b5f4b-b58c-445f-acf1-c7ce301bba648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-603-4037808060340355 mL in 1 BOTTLE (37808-603-40) 355 ml2016-04-110000-00-00NoNoCurrent