G-ZYNCOF

Product NDC: 52083-600
11-digit product format: 520830600
Labeler code: 52083
Product ID: 52083-600_a7c507ab-f326-4890-b26d-d80c59cacf8a
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr and Guaifenesin
Dosage form: SYRUP
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-12-03
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 400 mg/5mL; mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: G-ZYNCOF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/5mL
GUAIFENESIN	400 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1113368	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-600-16	G-ZYNCOF	473 mL in 1 BOTTLE, PLASTIC	SYRUP	473		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-600-16	ML - Milliliter	52083-600	edeaf9ed-dd8b-4828-abfe-35d4869c7394	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
POLYETHYLENE GLYCOL 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-600	G-ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	4	Current NDC, Legacy NDC, 1 package rows	20241012_c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 171 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	Warnings	Exact identifier application number: M012
Childrens Cough Mucus Relief	DEXTROMETHORPHANN HBR, GUAIFENESIN	Discount Drug Mart	2c27aca4-e1e2-419a-84c4-857718ca49da	2023-12-29	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	de2b2e34-62a5-451f-ab68-531d1c9d4d82	2023-12-29	Warnings	Exact identifier application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	d2b016ee-5329-45bf-9d71-d626204169cf	2023-12-29	Warnings	Exact identifier application number: M012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1113368	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 5 mL Oral Solution	PSN	c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	5
1113368	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution	SCD	c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	5
1113368	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution	SY	c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	5
1113368	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup	SY	c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-600-16	52083060016	473 mL in 1 BOTTLE, PLASTIC (52083-600-16)	473 ml	2012-12-03	0000-00-00	No	No	Current