FDA.reportPublic FDA data

Bionel

Product NDC
45737-207
11-digit product format
457370207
Labeler code
45737
Product ID
45737-207_27ff6a28-8f3a-4a42-9cc9-0fe1afb85799
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride
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; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/5mL; 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 productproduct45737-207IInactivated by FDA2026-08-17
excluded packagepackage45737-20745737-207-16IInactivated 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 packagepackage45737-207-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-207-169bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-207-162020-12-23C16284748780-19d75b9d0-2ef6-f424-e053-dadaa90a57ceAGC-BionelPed 207
45737-207-162020-01-31C16284748780-19d75b9d0-2ef6-f424-e053-dadaa90a57ceAGC-BionelPed 207

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-207-16BionelPediatric473 mL in 1 BOTTLELIQUID4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-207-16ML - Milliliter45737-207a2b5553c-6c2c-4c95-8fb3-0d7f39345fcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
GuaifenesinACTIVE INGREDIENT495W7451VQBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
DextromethorphanACTIVE MOIETY7355X3ROTSBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
GuaifenesinACTIVE MOIETY495W7451VQBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
PseudoephedrineACTIVE MOIETY7CUC9DDI9FBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
AspartameINACTIVE INGREDIENTZ0H242BBR1BIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
corn syrupINACTIVE INGREDIENT9G5L16BK6NBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
potassium citrateINACTIVE INGREDIENTEE90ONI6FFBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4BIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3BIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5
WaterINACTIVE INGREDIENT059QF0KO0RBIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-207BIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]8Legacy NDC, 1 package rows20241222_271c5895-25f5-4162-a278-6629b0ad03c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098911dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN271c5895-25f5-4162-a278-6629b0ad03c18
1098911dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD271c5895-25f5-4162-a278-6629b0ad03c18
1098911dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY271c5895-25f5-4162-a278-6629b0ad03c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-207-1645737020716473 mL in 1 BOTTLE (45737-207-16) 473 ml2009-10-010000-00-00NoNoCurrent