FDA.reportPublic FDA data

BIO Dtuss

Product NDC
45737-203
11-digit product format
457370203
Labeler code
45737
Product ID
45737-203_5ebcff2f-3f3a-436a-8ab1-44928941f2a1
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine
Dosage form
LIQUID
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 productproduct45737-203IInactivated by FDA2026-08-17
excluded packagepackage45737-20345737-203-16IInactivated by FDA2026-08-17

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 packagepackage45737-203-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-203-169bebd1f3094a…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
45737-203-162020-12-23C16284748780-19d75b9d0-3fe5-f424-e053-dadaa90a57ceAGC- BioDTussDMX 203
45737-203-162020-01-31C16284748780-19d75b9d0-3fe5-f424-e053-dadaa90a57ceAGC- BioDTussDMX 203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-203-16BIO DtussDMX473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-203-16ML - Milliliter45737-203de65ba53-2cc3-457c-81d0-310f9ed812c912020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03BIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554BIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RBIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-203BIO DTUSS DMX (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PSEUDOEPHEDRINE) LIQUID [ADVANCED GENERIC CORPORATION]6Legacy NDC, 1 package rows20241222_9eb28921-8917-4c82-9994-853e36c74431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245722brompheniramine maleate 1 MG / dextromethorphan HBr 20 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN9eb28921-8917-4c82-9994-853e36c744316
1245722brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD9eb28921-8917-4c82-9994-853e36c744316
1245722brompheniramine maleate 1 MG / dextromethorphan hydrobromide 20 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY9eb28921-8917-4c82-9994-853e36c744316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-203-1645737020316473 mL in 1 BOTTLE (45737-203-16) 473 ml2011-12-010000-00-00NoNoCurrent