G-TRON PEDIATRIC DROPS

Product NDC
52083-679
11-digit product format
520830679
Labeler code
52083
Product ID
52083-679_b60138fe-f319-4ed1-b13a-5ce5d0cbcce8
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr,Guaifenesin,Phenylephrine HCL
Dosage form
SOLUTION/ DROPS
Route
NASAL
Labeler
KRAMER NOVIS
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-09
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
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
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
52083-679-012023-01-30C16284748780-1f386c649-d4a5-0266-e053-dadaa90a7c1aG-TRON PEDIATRIC DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-679-01G-TRON PEDIATRIC DROPS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-679-01ML - Milliliter52083-67991f2dd05-9c15-4ffd-ac84-12df25bfe57f12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
GUAIFENESINACTIVE MOIETY495W7451VQG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
SORBITOLINACTIVE INGREDIENT506T60A25RG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RG-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-679G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2Legacy NDC, 1 package rows20191115_c3881560-a16d-492a-b2f3-032927cf890d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-679-015208306790130 mL in 1 BOTTLE, DROPPER (52083-679-01) 30 ml2014-09-090000-00-00NoNoCurrent