FDA.reportPublic FDA data

Biospec

Product NDC
45737-211
11-digit product format
457370211
Labeler code
45737
Product ID
45737-211_5c91244c-f997-481e-b9f2-b2814efc6e7d
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
2009-10-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
15 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 productproduct45737-211IInactivated by FDA2026-08-17
excluded packagepackage45737-21145737-211-16IInactivated 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 packagepackage45737-211-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-211-169bebd1f3094a…5416666fcb17…

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
45737-211-162020-12-23C16284748780-19d75b9d0-f02e-f424-e053-dadaa90a57ceAGC-BiospecDMX 211
45737-211-162020-01-31C16284748780-19d75b9d0-f02e-f424-e053-dadaa90a57ceAGC-BiospecDMX 211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-211-16BiospecDMX473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-211-16ML - Milliliter45737-211366314cf-d748-4286-80e0-0746847a272512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
GuaifenesinACTIVE INGREDIENT495W7451VQBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
DextromethorphanACTIVE MOIETY7355X3ROTSBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
GuaifenesinACTIVE MOIETY495W7451VQBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
MentholINACTIVE INGREDIENTL7T10EIP3ABIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
POTASSIUM GUAIACOLSULFONATEINACTIVE INGREDIENTTTK33Z47F1BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2
WaterINACTIVE INGREDIENT059QF0KO0RBIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-211BIOSPEC DMX (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]6Legacy NDC, 1 package rows20241222_54fcf605-39e9-47dd-ada4-1c4749af8dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476466dextromethorphan HBr 15 MG / guaiFENesin 25 MG in 5 mL Oral SolutionPSN54fcf605-39e9-47dd-ada4-1c4749af8dd86
476466dextromethorphan hydrobromide 3 MG/ML / guaifenesin 5 MG/ML Oral SolutionSCD54fcf605-39e9-47dd-ada4-1c4749af8dd86
476466dextromethorphan HBr 15 MG / guaifenesin 25 MG per 5 ML Oral SolutionSY54fcf605-39e9-47dd-ada4-1c4749af8dd86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-211-1645737021116473 mL in 1 BOTTLE (45737-211-16) 473 ml2009-10-010000-00-00NoNoCurrent