FDA.reportPublic FDA data

BioGtuss

Product NDC
45737-205
11-digit product format
457370205
Labeler code
45737
Product ID
45737-205_b3ffc52b-e4ae-4132-b066-5f11ac2a304e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin, 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
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
15 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 productproduct45737-205IInactivated by FDA2026-10-05
excluded packagepackage45737-20545737-205-16IInactivated 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 · 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 packagepackage45737-205-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-205-169bebd1f3094a…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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-205-162020-12-23C16284748780-19d75b9d0-c39d-f424-e053-dadaa90a57ceAGC-BioGTuss 205
45737-205-162020-01-31C16284748780-19d75b9d0-c39d-f424-e053-dadaa90a57ceAGC-BioGTuss 205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-205-16BioGtuss473 mL in 1 BOTTLELIQUID4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-205-16ML - Milliliter45737-2052f7a12d1-b2dd-4e1a-994c-c9aa229fe6f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
GuaifenesinACTIVE INGREDIENT495W7451VQBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
DextromethorphanACTIVE MOIETY7355X3ROTSBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
GuaifenesinACTIVE MOIETY495W7451VQBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
PhenylephrineACTIVE MOIETY1WS297W6MVBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
AspartameINACTIVE INGREDIENTZ0H242BBR1BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
Hydroxymethyl CelluloseINACTIVE INGREDIENT273FM27VK1BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4
WaterINACTIVE INGREDIENT059QF0KO0RBIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-205BIOGTUSS (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]8Legacy NDC, 1 package rows20241222_28c143f4-1575-44fe-871c-8e281322994e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251031dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN28c143f4-1575-44fe-871c-8e281322994e8
1251031dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD28c143f4-1575-44fe-871c-8e281322994e8
1251031dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY28c143f4-1575-44fe-871c-8e281322994e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-205-1645737020516473 mL in 1 BOTTLE (45737-205-16) 473 ml2009-10-010000-00-00NoNoCurrent