FDA.reportPublic FDA data

Cold and Cough DM

Product NDC
56062-987
11-digit product format
560620987
Labeler code
56062
Product ID
56062-987_9002c085-f7ae-4635-bfbc-dbd599a3e204
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-10
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 10; 5 mg/10mL; mg/10mL; mg/10mL
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
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
Cold and Cough DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal UNII lookup
9D2RTI9KYHInternal 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
1090463Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d5f93c1-7752-4948-ba58-c4385cfc24c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-987-26Cold and Cough DM1 in 1 CARTONSOLUTION15
56062-987-26Cold and Cough DM118 mL in 1 BOTTLESOLUTION1185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03COLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-987COLD AND COUGH DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [PUBLIX SUPER MARKETS INC]5Current NDC, Legacy NDC, 2 package rows20241119_4d5f93c1-7752-4948-ba58-c4385cfc24c8.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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.adb658c8-db8d-4db6-80c8-e0f2de88a2de2026-05-27WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacyc71427d4-707f-411f-8bd4-133517a9992b2026-05-26WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCVS PHARMACY, INC643e929d-9e62-4260-91ee-e88a184dd7cd2026-05-26WarningsExact identifier
application number: M012
TopCare Day Time Nite Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCc00ff684-acaf-4fbe-bc74-7e48751b927d2026-05-26WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PEPHENYLEPHRINECabinet Health P.B.C.4e75da23-35f2-431c-92cb-c2c4cb3f09f12026-05-26WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS Pharmacy13492631-d5de-4562-a201-664f7d3591de2026-05-26WarningsExact identifier
application number: M012
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
application number: M012
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsExact identifier
application number: M012
ClorReliefCHLORPHENIRAMINE MALEATEFERRER MEDICAL INNOVATIONS LLCdb729011-f72f-5911-e053-2a95a90a68bf2026-05-22WarningsExact identifier
application number: M012
Childrens Dye Free Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporation74ff4f0d-7952-4b74-b1b2-5a2beab91f7c2026-05-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN4d5f93c1-7752-4948-ba58-c4385cfc24c85
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD4d5f93c1-7752-4948-ba58-c4385cfc24c85
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY4d5f93c1-7752-4948-ba58-c4385cfc24c85
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY4d5f93c1-7752-4948-ba58-c4385cfc24c85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-987-26560620987261 BOTTLE in 1 CARTON (56062-987-26) / 118 mL in 1 BOTTLE1 bottle2014-02-100000-00-00NoNoCurrent