FDA.reportPublic FDA data

Biogtuss

Product NDC
45737-605
11-digit product format
457370605
Labeler code
45737
Product ID
45737-605_ba0e6be6-75a0-4449-b4cd-3538d17b461c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-04-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
388 mg/1; mg/1; mg/1
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 productproduct45737-605IInactivated by FDA2026-08-17
excluded packagepackage45737-60545737-605-10IInactivated 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 · 6 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 packagepackage45737-605-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-605-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage45737-605-10110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-605-102026-01-29C16284748780-19855e2a2-4062-60a7-e053-dbdaa90a05bdAGC-BioGTussTR 605
45737-605-102020-12-23C16284748780-19855e2a2-4062-60a7-e053-dbdaa90a05bdAGC-BioGTussTR 605
45737-605-102019-11-27C16284748780-19855e2a2-4062-60a7-e053-dbdaa90a05bdAGC-BioGTussTR 605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-605-10BiogtussTR100 in 1 BOTTLETABLET1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-605BIOGTUSS TR (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR) TABLET [ADVANCED GENERIC CORPORATION]5Legacy NDC, 1 package rows20241222_bdc5b26f-bb43-4a5e-ac00-5bae1414c3e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167784dextromethorphan HBr 28 MG / guaiFENesin 388 MG / phenylephrine HCl 10 MG Oral TabletPSNbdc5b26f-bb43-4a5e-ac00-5bae1414c3e55
2167784dextromethorphan hydrobromide 28 MG / guaifenesin 388 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDbdc5b26f-bb43-4a5e-ac00-5bae1414c3e55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-605-1045737060510100 TABLET in 1 BOTTLE (45737-605-10) 100 tablet2014-04-010000-00-00NoNoCurrent