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 83 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	20ae92d9-fbc6-5b7a-e063-6294a90a15c3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51c44970-06e5-082e-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	54236151-37db-0b5a-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	52542774-fd05-640c-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dca689-e4a0-5526-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f2d18f6-935f-9215-e053-2a91aa0aedd3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6fb28fa1-ebbb-64bf-e053-2991aa0a1de4	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5213ca7f-5a78-6471-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	6f7ba256-ed14-5fe0-e053-2a91aa0aacc1	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	6f7bf92d-4aaf-86e0-e053-2991aa0a2d91	2025-12-04	Warnings	Exact identifier application number: M012
Afrin NoDrip Allergy Sinus Night	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	b023a571-7e54-7c63-e053-2a95a90a0f78	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	Bayer HealthCare LLC.	b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3231869-8ddf-9d17-e053-2995a90ae6d5	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Multi Symptom Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ae7cf41e-b618-d6bb-e053-2a95a90a6692	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Allergy Sinus Nasal	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	c2d903bf-5c51-82d7-e053-2995a90aea49	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold, Cough and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	351d3c5c-05c8-921a-e063-6394a90abef9	2025-12-04	Warnings	Exact identifier application number: M012
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	e3b239bd-ffc7-600c-e053-2a95a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold Flu And Chest Congestion	ACETAMINOPHEN, GUAIFENESIN	Bayer HealthCare LLC.	de95d2dd-e766-f7ec-e053-2995a90afc5f	2025-12-04	Warnings	Exact identifier application number: M012
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	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