FDA.reportPublic FDA data

Biocotron-D

Product NDC
45737-208
11-digit product format
457370208
Labeler code
45737
Product ID
45737-208_09f2b66a-cbe2-4baf-a9a6-a55f0426cdd7
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 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 productproduct45737-208IInactivated by FDA2026-08-17
excluded packagepackage45737-20845737-208-16IInactivated 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 packagepackage45737-208-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-208-169bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-208-162020-12-23C16284748780-19d75b9d0-1483-f424-e053-dadaa90a57ceAGC-BiocotronDSus 208
45737-208-162020-01-31C16284748780-19d75b9d0-1483-f424-e053-dadaa90a57ceAGC-BiocotronDSus 208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-208-16Biocotron-D473 mL in 1 BOTTLESUSPENSION/ DROPS4736

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-208BIOCOTRON-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SUSPENSION/ DROPS [ADVANCED GENERIC CORPORATION]6Legacy NDC, 1 package rows20241222_d1da2b49-af3a-4b80-a62c-c9147dab3113.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486140dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral SuspensionPSNd1da2b49-af3a-4b80-a62c-c9147dab31136
1486140dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SuspensionSCDd1da2b49-af3a-4b80-a62c-c9147dab31136
1486140dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral SuspensionSYd1da2b49-af3a-4b80-a62c-c9147dab31136
1486140dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral SuspensionSYd1da2b49-af3a-4b80-a62c-c9147dab31136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-208-1645737020816473 mL in 1 BOTTLE (45737-208-16) 473 ml2013-03-010000-00-00NoNoCurrent