FDA.reportPublic FDA data

EndaCof DM

Product NDC
68047-143
11-digit product format
680470143
Labeler code
68047
Product ID
68047-143_4139510b-7402-8fec-e063-6294a90a4b20
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Larken Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-30
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
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
EndaCof DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

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
c68ea55a-8b9a-4a70-8b5c-1a2736651813Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68047-143-16EndaCof DM473 mL in 1 BOTTLELIQUID47313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-143-16ML - Milliliter68047-14393208cee-423c-43de-bcb2-b74025210b0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03ENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-143ENDACOF DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20241012_c68ea55a-8b9a-4a70-8b5c-1a2736651813.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 166 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b80dae7f-ed2d-4a9e-bef9-f1ed8add01742024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREENSc945c35e-de0d-0fd6-e053-2995a90a1fbf2024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCLWalgreensda046b01-707c-326a-e053-2995a90a09272024-03-19WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2b0276-9ab0-38e6-e053-2a95a90a54d82024-03-19WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact identifier
application number: M012
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutions5f2b16f0-c58b-4e48-ad92-eaab93c6c4b22024-03-12WarningsExact identifier
application number: M012
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger FlavorACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC18dcede2-5a38-40fa-93fe-48acdd6a7cf12024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry FlavorACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCd4ce06aa-776f-45e4-a1a6-9cf13797048f2024-03-08WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC14e38ef0-a5e7-4df7-824f-f27bef664d252024-03-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC68d3e88a-d1be-410b-92a1-863903b3aa612024-03-08WarningsExact 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 SolutionPSNc68ea55a-8b9a-4a70-8b5c-1a273665181313
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDc68ea55a-8b9a-4a70-8b5c-1a273665181313
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYc68ea55a-8b9a-4a70-8b5c-1a273665181313
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYc68ea55a-8b9a-4a70-8b5c-1a273665181313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-143-1668047014316473 mL in 1 BOTTLE (68047-143-16) 473 ml2012-03-300000-00-00NoNoCurrent