FDA.reportPublic FDA data

Biocotron

Product NDC
45737-209
Requested package NDC
45737-209-16
11-digit product format
457370209
Labeler code
45737
Product ID
45737-209_6064d4a6-914d-4c9b-847a-f6da938540ab
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45737-20945737-209-16IInactivated by FDA2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45737-20945737-209-16IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-20945737-209-16IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-209-162020-12-23C16284748780-19d75b9d0-f8ef-f424-e053-dadaa90a57ceAGC-Biocotron 209
45737-209-162020-01-31C16284748780-19d75b9d0-f8ef-f424-e053-dadaa90a57ceAGC-Biocotron 209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-209-16Biocotron473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-209-16ML - Milliliter45737-20933c913b0-ded1-46f8-a9d8-a7f4d68aaaa912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBIOCOTRON - (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GuaifenesinACTIVE INGREDIENT495W7451VQBIOCOTRON - (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
DextromethorphanACTIVE MOIETY7355X3ROTSBIOCOTRON - (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GuaifenesinACTIVE MOIETY495W7451VQBIOCOTRON - (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-209BIOCOTRON (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]9Legacy NDC, 1 package rows20241228_91d90a98-38ce-46f0-a31a-ac00937474aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN91d90a98-38ce-46f0-a31a-ac00937474aa9
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD91d90a98-38ce-46f0-a31a-ac00937474aa9
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY91d90a98-38ce-46f0-a31a-ac00937474aa9
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY91d90a98-38ce-46f0-a31a-ac00937474aa9
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY91d90a98-38ce-46f0-a31a-ac00937474aa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-209-1645737020916473 mL in 1 BOTTLE (45737-209-16) 473 ml2009-01-010000-00-00NoNoCurrent