FDA.reportPublic FDA data

Biocotron

Product NDC
45737-261
11-digit product format
457370261
Labeler code
45737
Product ID
45737-261_465fc4d2-eac7-4b1e-9096-9b2d4f5851fc
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
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; PHENYLEPHRINE HYDROCHLORIDE
Active strength
15 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 productproduct45737-261IInactivated by FDA2026-08-17
excluded packagepackage45737-26145737-261-16IInactivated 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 packagepackage45737-261-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-261-169bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-261-162020-12-23C16284748780-19d75b9d0-af15-f424-e053-dadaa90a57ceAGC-Biocotron Ped 261
45737-261-162020-01-31C16284748780-19d75b9d0-af15-f424-e053-dadaa90a57ceAGC-Biocotron Ped 261

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-261-16BiocotronPED473 mL in 1 BOTTLELIQUID4735

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662BIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RBIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-261BIOCOTRON PED (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]5Legacy NDC, 1 package rows20241222_53097e28-ff2a-4ceb-9c95-d75d7ae511b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372451dextromethorphan HBr 15 MG / guaiFENesin 350 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN53097e28-ff2a-4ceb-9c95-d75d7ae511b85
1372451dextromethorphan hydrobromide 3 MG/ML / guaifenesin 70 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD53097e28-ff2a-4ceb-9c95-d75d7ae511b85
1372451dextromethorphan HBr 15 MG / guaifenesin 350 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY53097e28-ff2a-4ceb-9c95-d75d7ae511b85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-261-1645737026116473 mL in 1 BOTTLE (45737-261-16) 473 ml2015-03-010000-00-00NoNoCurrent