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: 2026-12-31

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 137 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Oxymetazoline Sinus Severe	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	13237d31-c60a-49f8-9b96-4414cf766a08	2024-11-21	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier application number: M012
Halls Green Apple	MENTHOL	Mondelez Global LLC	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	2024-11-20	Warnings	Exact identifier application number: M012
Halls Blueberry	MENTHOL	Mondelez Global LLC	275a6935-ea44-486e-e063-6394a90ae19a	2024-11-20	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	234bd567-4e3c-419f-a000-fdfc28cafc8b	2024-11-20	Warnings	Exact identifier application number: M012
NICE Assorted Cough Drops	MENTHOL	Leosons Overseas Corp	96db0f37-41cc-1ebd-e053-2a95a90a3215	2024-11-19	Warnings	Exact identifier application number: M012
Nice Cherry Cough Drops	MENTHOL	Leosons Overseas Corp	98e52604-6e41-6408-e053-2995a90a6bc8	2024-11-19	Warnings	Exact identifier application number: M012
NICE Citrus Cough Drops	MENTHOL	Leosons Overseas Corp	96d9527d-9bf9-ce82-e053-2995a90aff0c	2024-11-19	Warnings	Exact identifier application number: M012
NICE Menthol Cough Drops	MENTHOL	Leosons Overseas Corp	96d77897-475c-482c-e053-2995a90a2da4	2024-11-19	Warnings	Exact identifier application number: M012
NICE Honey Lemon Cough Drops	MENTHOL	Leosons Overseas Corp	96da2c9d-2d0d-6252-e053-2995a90ac338	2024-11-19	Warnings	Exact identifier application number: M012
SanaTos Boost	DEXTROMETHORPHAN HBR	Pharmadel LLC	ae6a424f-f3f0-3f6c-e053-2995a90a972d	2024-11-18	Warnings	Exact identifier application number: M012
SanaTos Turbo Max Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	d56a071c-a747-5397-e053-2995a90aad8b	2024-11-18	Warnings	Exact identifier application number: M012
cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	404ef5f4-7b7b-4c08-b159-9175a91be132	2024-11-17	Warnings	Exact identifier application number: M012
equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a24021a0-ef68-4bce-ba53-d262d1025cc0	2024-11-17	Warnings	Exact identifier application number: M012
Cold and Cough DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	4d5f93c1-7752-4948-ba58-c4385cfc24c8	2024-11-17	Warnings	Exact identifier application number: M012
Good Sense Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	8a87104f-94a4-4585-afd5-d610eea32e39	2024-11-17	Warnings	Exact identifier application number: M012
equate childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4	2024-11-17	Warnings	Exact identifier application number: M012
foster and thrive childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services LLC	1eac715b-351c-4b47-8d1d-6e921813c1a4	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	298d2796-5ae5-4346-b6d2-2ced2dd29dc3	2024-11-15	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief night time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	f721b393-9ad5-4fc6-a2c5-bd89e58caf16	2024-11-15	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