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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
application number: M012
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
application number: M012
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd9f26677-ddef-4098-b564-9aa5734e088b2025-10-09WarningsExact identifier
application number: M012
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
application number: M012
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc020942b1-59d4-a19d-e063-6394a90a5d872025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 200ctMENTHOLDollar General Corporationa17aece2-abd8-452a-9da8-2e303845900b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporation51ccf39a-ae9b-4e6a-856c-002c296f5d072025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporationf85f1a15-db7f-4bb5-9313-24702660054e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporationd5fb7d9e-b0f6-4424-bf67-9e72b50366b12025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporationa23ec89a-de7e-4013-b85b-1593e18dc28e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation1833d3bf-6f01-4122-9f4d-4d8b2423fcbb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact 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