FDA.reportPublic FDA data

Medique Cold Cough Product

Product NDC
85766-162
11-digit product format
857660162
Labeler code
85766
Product ID
85766-162_4a5ea172-8d70-4e54-e063-6394a90a4fd1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ,
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Medique Cold Cough Product
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal 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
1094538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-162-36Medique Cold Cough Product75 in 1 BOXTABLET, FILM COATED751
85766-162-36Medique Cold Cough Product2 in 1 PACKETTABLET, FILM COATED21
85766-162-80Medique Cold Cough Product40 in 1 BOXTABLET, FILM COATED401
85766-162-80Medique Cold Cough Product2 in 1 PACKETTABLET, FILM COATED21

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 58 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012
Vapo SteamVAPO STEAMTOPCO ASSOCIATES, LLCf216f69f-9580-25ac-e053-2995a90a5ac62026-01-14WarningsExact identifier
application number: M012
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
application number: M012
Sinus PE plus AllergyCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLWalgreen Companya15979d4-87bf-42e7-b1f2-7834960721412026-01-13WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.4260542e-0980-4b0b-8177-1c9f2c53b5a62026-01-13WarningsExact identifier
application number: M012
Sweet ComfortMENTHOLSaje Natural Business Inc.cf13cccd-723d-4d61-8a5e-b36281605cc72026-01-13WarningsExact identifier
application number: M012
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
application number: M012
Rolling FarmacyMENTHOLSaje Natural Business Inc.a38765a9-22cd-4fc5-b5ab-c3cacbd52c742026-01-13WarningsExact identifier
application number: M012
Home FarmacyMENTHOLSaje Natural Business Inc.add35d10-b27a-4ae8-b2de-8a285aaef1552026-01-13WarningsExact identifier
application number: M012
Traveling FarmacyMENTHOLSaje Natural Business Inc.5b70f5aa-ed36-65ab-e053-2a91aa0a67772026-01-13WarningsExact identifier
application number: M012
sinus plus allergy PE maximum strengthCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI660d3c80-f249-41dd-aa93-a0b1e635ead02026-01-13WarningsExact identifier
application number: M012
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLH E Bc9e977b6-fba6-49ea-9d80-b43b0842bbe12026-01-12WarningsExact identifier
application number: M012
PE Sinus CongestionPHENYLEPHRINE HCLTopco Associates, LLC3264e291-7a0f-4e25-8390-ba441f22f6502026-01-12WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACY3f44cff6-240a-4a8d-aaa1-0da75a31a47b2026-01-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094538acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral TabletPSNd61df3a4-8ae2-46b1-b322-7f4e04cc1bf91
1094538acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDd61df3a4-8ae2-46b1-b322-7f4e04cc1bf91
1094538APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral TabletSYd61df3a4-8ae2-46b1-b322-7f4e04cc1bf91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-162-368576601623675 PACKET in 1 BOX (85766-162-36) / 2 TABLET, FILM COATED in 1 PACKET75 packet2026-02-09NoNoCurrent
85766-162-808576601628040 PACKET in 1 BOX (85766-162-80) / 2 TABLET, FILM COATED in 1 PACKET40 packet2026-02-09NoNoCurrent