FDA.reportPublic FDA data

Bio-G-Tuss

Product NDC
45737-240
11-digit product format
457370240
Labeler code
45737
Product ID
45737-240_7d649187-a213-4d0d-be73-571cca8a19d5
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
8 mg/mL; mg/mL; mg/mL
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 productproduct45737-240IInactivated by FDA2026-08-17
excluded packagepackage45737-24045737-240-02IInactivated 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 packagepackage45737-240-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-240-029bebd1f3094a…5416666fcb17…

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
45737-240-022020-12-23C16284748780-19d75b9d1-1d22-f424-e053-dadaa90a57ceAGC-BioGTuss Ped Dr 240
45737-240-022020-01-31C16284748780-19d75b9d1-1d22-f424-e053-dadaa90a57ceAGC-BioGTuss Ped Dr 240

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-240-02Bio-G-TussPediatric Drops60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-240BIO-G-TUSS PEDIATRIC DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]4Legacy NDC, 1 package rows20241222_42045759-eaf2-4ffb-8a68-043f661acf8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487369dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSN42045759-eaf2-4ffb-8a68-043f661acf8a4
1487369dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCD42045759-eaf2-4ffb-8a68-043f661acf8a4
1487369dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 ML Oral SolutionSY42045759-eaf2-4ffb-8a68-043f661acf8a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-240-024573702400260 mL in 1 BOTTLE, DROPPER (45737-240-02) 60 ml2016-04-010000-00-00NoNoCurrent