FDA.reportPublic FDA data

Bio-S-Pres

Product NDC
45737-230
11-digit product format
457370230
Labeler code
45737
Product ID
45737-230_b4c750b5-60bd-4135-a52f-529f315f3847
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
2013-03-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
45737-230-012020-12-23C16284748780-19d75b9d0-5101-f424-e053-dadaa90a57ceAGC-BioSPressDX 230
45737-230-012020-01-31C16284748780-19d75b9d0-5101-f424-e053-dadaa90a57ceAGC-BioSPressDX 230

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-230-01Bio-S-PresDX30 mL in 1 BOTTLESOLUTION/ DROPS305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
SACCHARIN CALCIUMINACTIVE INGREDIENT5101OP7P2IBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-230BIO-S-PRES DX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]5Legacy NDC, 1 package rows20241222_b3b9c298-4524-4ba7-a831-3bf3c2950e27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095503dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSNb3b9c298-4524-4ba7-a831-3bf3c2950e275
1095503dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCDb3b9c298-4524-4ba7-a831-3bf3c2950e275
1095503dextromethorphan HBr 5 MG / guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral DropsSYb3b9c298-4524-4ba7-a831-3bf3c2950e275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-230-014573702300130 mL in 1 BOTTLE (45737-230-01) 30 ml2013-03-010000-00-00NoNoCurrent