FDA.reportPublic FDA data

G-TRON

Product NDC
52083-678
11-digit product format
520830678
Labeler code
52083
Product ID
52083-678_7d8d222b-b7a2-4165-b432-d400969ec490
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Kramer Novis
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-27
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
2020-12-31
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
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-678-162025-01-30C16284748780-12cef2736-64f0-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-678-16G-TRONPED474 mL in 1 BOTTLESOLUTION4743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-678-16ML - Milliliter52083-67887ddc87e-07ab-4abc-a75a-52f4d03c705a12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)INACTIVE INGREDIENTB24JYI97VRG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
SORBITOLINACTIVE INGREDIENT506T60A25RG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RG-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-678G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]3Legacy NDC, 1 package rows20190919_75cd3241-e571-4b50-b03a-1715dc747825.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 SolutionPSN75cd3241-e571-4b50-b03a-1715dc7478253
1372451dextromethorphan hydrobromide 3 MG/ML / guaifenesin 70 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD75cd3241-e571-4b50-b03a-1715dc7478253
1372451dextromethorphan HBr 15 MG / guaifenesin 350 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY75cd3241-e571-4b50-b03a-1715dc7478253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-678-1652083067816474 mL in 1 BOTTLE (52083-678-16) 474 ml2014-01-270000-00-00NoNoCurrent