FDA.reportPublic FDA data

Conex

Product NDC
54859-702
11-digit product format
548590702
Labeler code
54859
Product ID
54859-702_472e27dc-944c-73bf-e063-6294a90a21b9
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Pseudoephedrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-11-01
Substance
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54859-702IInactivated by FDA2026-08-03
excluded packagepackage54859-70254859-702-60IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54859-702-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54859-702-609bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-702-602020-12-23C16284748780-19d75b9d0-1486-f424-e053-dadaa90a57ceConex Tab Allergy 702
54859-702-602020-01-31C16284748780-19d75b9d0-1486-f424-e053-dadaa90a57ceConex Tab Allergy 702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-702-60Conex60 in 1 BOTTLETABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-702-60EA - Each54859-70231e821dd-b951-472b-b0d5-0b8bdce2e12512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1
WATERINACTIVE INGREDIENT059QF0KO0RCONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-702CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]5Current NDC, Legacy NDC, 1 package rows20241222_82f9f52c-797e-4842-9c9a-40213181d99a.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN82f9f52c-797e-4842-9c9a-40213181d99a8
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD82f9f52c-797e-4842-9c9a-40213181d99a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-702-605485907026060 TABLET in 1 BOTTLE (54859-702-60) 60 tablet2007-11-010000-00-00NoNoCurrent