FDA.reportPublic FDA data

Bionatuss

Product NDC
45737-210
11-digit product format
457370210
Labeler code
45737
Product ID
45737-210_2c36395e-c0a5-42a6-ba75-977b33b65aac
Type
HUMAN OTC DRUG
Nonproprietary name
Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-10-01
Marketing end
0000-00-00
Substance
DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2 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 productproduct45737-210IInactivated by FDA2026-08-17
excluded packagepackage45737-21045737-210-16IInactivated 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 packagepackage45737-210-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-210-169bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-210-162020-12-23C16284748780-19d75b9d0-0b2c-f424-e053-dadaa90a57ceAGC-BionatussDXP 210
45737-210-162020-01-31C16284748780-19d75b9d0-0b2c-f424-e053-dadaa90a57ceAGC-BionatussDXP 210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-210-16BionatussDXP473 mL in 1 BOTTLELIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-210-16ML - Milliliter45737-21082188ca6-b26d-458a-a354-1a10f465bbe112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-210BIONATUSS DXP (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4Legacy NDC, 1 package rows20241222_e57de19a-bf2f-405c-bc84-6ccae6055a46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300164dexbrompheniramine maleate 2 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSNe57de19a-bf2f-405c-bc84-6ccae6055a464
1300164dexbrompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCDe57de19a-bf2f-405c-bc84-6ccae6055a464
1300164dexbrompheniramine maleate 2 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSYe57de19a-bf2f-405c-bc84-6ccae6055a464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-210-1645737021016473 mL in 1 BOTTLE (45737-210-16) 473 ml2009-10-010000-00-00NoNoCurrent