FDA.reportPublic FDA data

Medique Decorel Forte

Product NDC
47682-435
11-digit product format
476820435
Labeler code
47682
Product ID
47682-435_3e4fe7f8-b07f-5ac2-e063-6394a90afc08
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-26
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 325; 10; 100 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
Medique Decorel Forte
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal 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
e64c283b-0efa-0bfd-e053-2a95a90ab71dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-435-36Medique Decorel Forte75 in 1 BOXTABLET, FILM COATED755
47682-435-80Medique Decorel Forte40 in 1 BOXTABLET, FILM COATED405
47682-435-99Medique Decorel Forte2 in 1 PACKETTABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-435MEDIQUE DECOREL FORTE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST PLUS COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 3 package rows20240915_e64c283b-0efa-0bfd-e053-2a95a90ab71d.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 165 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)f958d8ba-ede9-4b1a-8317-2404b68a91292024-05-03WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLCfab57d70-ba54-416f-9f14-b64d2238ea162024-05-03WarningsExact identifier
application number: M012
Tussin CF Non Drowsy Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLC8ee27600-4f8e-406a-8ea3-eade691448f62024-05-03WarningsExact identifier
application number: M012
SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBR AND GUAIFENESINPharmadel LLC60437d86-9e13-8d8a-e053-2991aa0a23172024-05-02WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact identifier
application number: M012
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat NighttimeACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHaleon US Holdings LLC7decc168-e847-4bbe-910b-26081469406f2024-04-26WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC7c92bdcf-db1f-4299-982f-6a3da9cba6e62024-04-25WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC15727e06-7bfc-424e-9e68-cc9cd5695bfd2024-04-25WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC5872fed8-862b-44a2-a06e-51ebf86182712024-04-25WarningsExact identifier
application number: M012
CHERRY COUGH DROPS 50CTMENTHOL, UNSPECIFIED FORMJHK Inc dba American Safety & First Aid2f54b9c1-3a37-48fd-b964-6aa2631b8e622024-04-24WarningsExact identifier
application number: M012
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)fc7954a6-d061-4160-b1d1-a19eb9eabff42024-04-22WarningsExact identifier
application number: M012
Dibromm Cold and Allergy ChildrensBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)ea285d5a-9eb4-4f71-bb1b-4e24a89728192024-04-22WarningsExact 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 TabletPSNe64c283b-0efa-0bfd-e053-2a95a90ab71d5
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe64c283b-0efa-0bfd-e053-2a95a90ab71d5
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe64c283b-0efa-0bfd-e053-2a95a90ab71d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-435-364768204353675 PACKET in 1 BOX (47682-435-36) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 75 packet2022-12-120000-00-00NoNoCurrent
47682-435-804768204358040 PACKET in 1 BOX (47682-435-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) 40 packet2022-09-260000-00-00NoNoCurrent
47682-435-99476820435992 TABLET, FILM COATED in 1 PACKET (47682-435-99) 2022-09-26NoNoCurrent