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 48 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Daytime Cough and Nighttime Cough combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEGenexa Inc.4bad39f1-86d4-b8a1-e063-6394a90a7a952026-02-25WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals67072a38-1ae7-4e59-bfed-71db0d93215d2026-02-25WarningsExact identifier
application number: M012
leader tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderb3e3699b-b36c-453c-8f3b-0001388c8e822026-02-25WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
VaproizingCAMPHORH E B577fda09-588a-4c2e-ada5-eeda32d1aabe2026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
application number: M012
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
application number: M012
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
application number: M012
Cough DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED39adf23e-76f3-42e1-a9f4-55feb38078e52026-02-24WarningsExact identifier
application number: M012
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands47317865-4310-4f07-8815-f3130963307d2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Brands42720fa0-fcdd-4614-80b2-16d0ada345b12026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brandscc09a8c5-d173-4261-b838-96e6a16e2ff92026-02-23WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands96a1055f-e831-4f4b-8af3-7a41838c194c2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Brands1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2462026-02-23WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBetter Living Brands, LLC0948648c-1c5f-4225-a754-120ca8859f192026-02-23Warnings, Adverse reactionsExact identifier
application number: M012
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
application number: M012
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact 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