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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52083-678		I	Inactivated by FDA		2026-10-05
excluded package	package	52083-678	52083-678-16	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52083-678-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52083-678-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52083-678-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52083-678-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52083-678-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52083-678-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52083-678-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52083-678-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52083-678-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-678-16	2025-01-30	C162847	48780-1	2cef2736-64f0-d83d-e063-dadaa90ab31f	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-678-16	G-TRONPED	474 mL in 1 BOTTLE	SOLUTION	474		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-678-16	ML - Milliliter	52083-678	87ddc87e-07ab-4abc-a75a-52f4d03c705a	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)	INACTIVE INGREDIENT	B24JYI97VR	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-678	G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]	3	Legacy NDC, 1 package rows	20190919_75cd3241-e571-4b50-b03a-1715dc747825.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372451	dextromethorphan HBr 15 MG / guaiFENesin 350 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution	PSN	75cd3241-e571-4b50-b03a-1715dc747825	3
1372451	dextromethorphan hydrobromide 3 MG/ML / guaifenesin 70 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution	SCD	75cd3241-e571-4b50-b03a-1715dc747825	3
1372451	dextromethorphan HBr 15 MG / guaifenesin 350 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution	SY	75cd3241-e571-4b50-b03a-1715dc747825	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-678-16	52083067816	474 mL in 1 BOTTLE (52083-678-16)	474 ml	2014-01-27	0000-00-00	No	No	Current