ZYNCOF

Product NDC: 52083-400
11-digit product format: 520830400
Labeler code: 52083
Product ID: 52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f
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: 2011-06-01
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: 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
cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	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	SPL version
52083-400-01	ZYNCOF	30 mL in 1 BOTTLE, PLASTIC	SYRUP	30	6
52083-400-04	ZYNCOF	120 mL in 1 BOTTLE, PLASTIC	SYRUP	120	6
52083-400-16	ZYNCOF	474 mL in 1 BOTTLE, PLASTIC	SYRUP	474	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-400-01	ML - Milliliter	52083-400	f9c657ae-aa72-410c-a3a1-3a2b10c2a7b0	1	2017-04-05
52083-400-04	ML - Milliliter	52083-400	601296d5-d808-4845-a5be-af602f497ea0	1	2012-07-24
52083-400-16	ML - Milliliter	52083-400	845a08ee-89d4-4d5a-9ff6-03c1e02384b8	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
POLYETHYLENE GLYCOL 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52083-400	ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS]	5	Current NDC, Legacy NDC, 3 package rows	20241012_cffd6d5f-0cb2-4d38-bdb0-6a21120418cc.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 158 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herbal Flavor Menthol Cough Drops	HERBAL FLAVOR MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb848b6-3dec-5b5f-e063-6394a90aea14	2024-08-02	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb8927b-22c5-2ca3-e063-6294a90aa563	2024-08-02	Warnings	Exact identifier application number: M012
No Drip Severe Anefrin Nasal	0.05% OXYMETAZOLINE HCL	Walgreens Company	c126e969-56f3-47b4-a011-02ff150eccb8	2024-08-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HCL	A-S Medication Solutions	0e81a937-59e5-4869-8ffb-c758fb37230d	2024-07-23	Warnings	Exact identifier application number: M012
WesTussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Westminster Pharmaceuticals, LLC	68a0cd44-3fdd-430e-af1a-498d4415ab78	2024-07-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Lil' Drug Store Products, Inc.	edc244d6-eb0b-d3c9-e053-2a95a90a2622	2024-07-22	Warnings	Exact identifier application number: M012
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9	2024-07-22	Warnings	Exact identifier application number: M012
CareOne Childrens Allergy Relief	DIPHENHYDRAMINE HCL	American Sales Company	bb78ef2c-4f42-4e8f-b38d-f9b2965a384b	2024-07-19	Warnings	Exact identifier application number: M012
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	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	cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	6
1113368	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Oral Solution	SCD	cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	6
1113368	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG per 5 ML Oral Solution	SY	cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	6
1113368	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML Syrup	SY	cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52083-400-01	52083040001	30 mL in 1 BOTTLE, PLASTIC (52083-400-01)	30 ml	2011-06-01	0000-00-00	No	No	Current
52083-400-04	52083040004	120 mL in 1 BOTTLE, PLASTIC (52083-400-04)	120 ml	2011-06-01	0000-00-00	No	No	Current
52083-400-16	52083040016	474 mL in 1 BOTTLE, PLASTIC (52083-400-16)	474 ml	2013-01-23	0000-00-00	No	No	Current