FDA.reportPublic FDA data

Bio-Z-Cough

Product NDC
45737-251
11-digit product format
457370251
Labeler code
45737
Product ID
45737-251_47435899-03bb-ae43-e063-6394a90ad15a
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Advanced Generic Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bio-Z-Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
GUAIFENESIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1113368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
45737-251-162020-12-23C16284748780-19d75b9d0-038b-f424-e053-dadaa90a57ceAGC-BioZCough 251
45737-251-162020-01-31C16284748780-19d75b9d0-038b-f424-e053-dadaa90a57ceAGC-BioZCough 251

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-251-16Bio-Z-Cough473 mL in 1 BOTTLELIQUID4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-251-16ML - Milliliter45737-2519a6463f4-421c-46e7-aa9a-b83a9274ce7212025-07-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662BIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ABIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-251BIO-Z-COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]6Current NDC, Legacy NDC, 1 package rows20241228_05e70eab-1467-4b09-991e-ef03f222e021.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113368dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral SolutionPSN05e70eab-1467-4b09-991e-ef03f222e0217
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral SolutionSCD05e70eab-1467-4b09-991e-ef03f222e0217
1113368dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral SolutionSY05e70eab-1467-4b09-991e-ef03f222e0217
1113368dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML SyrupSY05e70eab-1467-4b09-991e-ef03f222e0217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-251-1645737025116473 mL in 1 BOTTLE (45737-251-16) 473 ml2012-07-010000-00-00NoNoCurrent