FDA.reportPublic FDA data

Biospec

Product NDC
45737-264
11-digit product format
457370264
Labeler code
45737
Product ID
45737-264_2a2354c5-aee5-4dc9-b397-3d10c72a9b58
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
2015-03-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45737-264IInactivated by FDA2026-08-17
excluded packagepackage45737-26445737-264-16IInactivated 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 packagepackage45737-264-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-264-169bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-264-162020-12-23C16284748780-19d75b9d0-f580-f424-e053-dadaa90a57ceAGC-BiospecDMX 264
45737-264-162020-01-31C16284748780-19d75b9d0-f580-f424-e053-dadaa90a57ceAGC-BiospecDMX 264

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-264-16BiospecDMX473 mL in 1 BOTTLELIQUID4733

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GuaifenesinACTIVE INGREDIENT495W7451VQBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
DextromethorphanACTIVE MOIETY7355X3ROTSBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GuaifenesinACTIVE MOIETY495W7451VQBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-264BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]3Legacy NDC, 1 package rows20241222_eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441364dextromethorphan HBr 10 MG / guaiFENesin 187 MG in 5 mL Oral SolutionPSNeb29e7cc-e6bb-4b33-88ee-aa3acd6f29703
1441364dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML Oral SolutionSCDeb29e7cc-e6bb-4b33-88ee-aa3acd6f29703
1441364dextromethorphan hydrobromide 10 MG / guaifenesin 187 MG per 5 ML Oral SolutionSYeb29e7cc-e6bb-4b33-88ee-aa3acd6f29703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-264-1645737026416473 mL in 1 BOTTLE (45737-264-16) 473 ml2015-03-010000-00-00NoNoCurrent