VanaCof 2

Product NDC: 58809-190
11-digit product format: 588090190
Labeler code: 58809
Product ID: 58809-190_47e37a4b-be9d-3c99-e063-6394a90ac7c7
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol HCl, Dexchlorpheniramine Maleate
Dosage form: SOLUTION
Route: ORAL
Labeler: GM Pharmaceuticals, INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-14
Substance: DEXCHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active strength: 1; 12.5 mg/5mL; mg/5mL
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: VanaCof 2
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXCHLORPHENIRAMINE MALEATE	1 mg/5mL
CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B10YD955QW	Internal UNII lookup
69QQ58998Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2671454	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
0c7c6756-abb2-c10c-e063-6394a90a9863	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
44893bf2-1be4-4e68-8bc4-bbb0f543085e	Product name	1	20180830
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-190-16	VanaCof 2	473 mL in 1 BOTTLE	SOLUTION	473		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-190-16	ML - Milliliter	58809-190	edef72bb-08fc-47b0-a927-d3361f5045bc	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-190	VANACOF 2 (CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE) SOLUTION [GM PHARMACEUTICALS, INC]	4	Current NDC, 1 package rows	20240202_0c7c6756-abb2-c10c-e063-6394a90a9863.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 176 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER PLUS Cold Day and Night Effervescent	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Sincronia Logistica, S.A. de C.V.	c478df69-823a-4112-8f44-323249a9f38f	2023-10-23	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	169006cb-7dc2-4113-a289-0b1f14e784b7	2023-10-23	Warnings	Exact identifier application number: M012
Night-Time Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	HealthLife of USA	2ffd62a6-703f-4cb0-bb13-49719c004d00	2023-10-21	Warnings	Exact identifier application number: M012
Day-Time Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN	HealthLife of USA	c5f6cf22-2aaa-40e1-b7b3-448e55898d62	2023-10-21	Warnings	Exact identifier application number: M012
PENTREXCILINA	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Healthlife of USA	ae9ada14-0ec8-4c01-a874-237f2108936a	2023-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	APNAR PHARMA LP	e5004c10-3877-c199-e053-2a95a90aa8ac	2023-10-21	Boxed warning, Warnings	Exact identifier application number: M012
Day and Night Multi Symptom Cold and Flu Relief	DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF	Intrivo Diagnostics Inc.	a311bf39-de6c-4ed5-949e-718ad8be1e49	2023-10-13	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0d65c4a9-938c-4a89-b1f1-d9ada8a8c587	2023-10-10	Warnings	Exact identifier application number: M012
Triacting Daytime Cold Cough Childrens	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8656aa2e-9546-4de4-9ecc-ce99bf903333	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	a33ae35b-1cde-4a3d-a836-3b169e4f1bb9	2023-10-10	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	553d01a9-e8ad-4797-b55b-32f134f08af9	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	8781e2c5-ad46-4615-a0d9-879590e86f95	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	419df833-1f33-45cf-bab3-730c928d5887	2023-10-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	93a5cb36-3262-4224-a5be-5ea1619a67bd	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	CVS Pharmacy	782fb103-cd9f-4e8c-8f3a-1fb131b9eda6	2023-10-09	Warnings	Exact identifier application number: M012
Cold and Congestion Childrens Nighttime	DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL	Walgreens	a7847413-e556-4f88-8a7f-a8528afbe927	2023-10-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	06d2c6cf-0adb-91b9-e063-6294a90aff52	2023-10-03	Warnings	Exact identifier application number: M012
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b	2023-10-02	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	ac8c0c15-b305-47f2-8712-e4b53636f7fa	2023-10-02	Warnings	Exact identifier application number: M012
Maximum strength Day cold and flu and Night severe cold and flu	ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS	TIME CAP LABORATORIES,INC	fff69901-965c-5372-e053-6394a90a29c2	2023-09-18	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B10YD955QW	DEXCHLORPHENIRAMINE MALEATE	2438-32-6	DEXCHLORPHENIRAMINE MALEATE
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2671454	chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG in 5 mL Oral Solution	PSN	0c7c6756-abb2-c10c-e063-6394a90a9863	5
2671454	chlophedianol hydrochloride 2.5 MG/ML / dexchlorpheniramine maleate 0.2 MG/ML Oral Solution	SCD	0c7c6756-abb2-c10c-e063-6394a90a9863	5
2671454	chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG per 5 ML Oral Solution	SY	0c7c6756-abb2-c10c-e063-6394a90a9863	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58809-190-16	58809019016	473 mL in 1 BOTTLE (58809-190-16)	473 ml	2023-12-14	No	No	Current