VANACOF

Product NDC: 58809-999
11-digit product format: 588090999
Labeler code: 58809
Product ID: 58809-999_412140cc-b107-571d-e063-6394a90a27cd
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: GM Pharmaceuticals, INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-04-22
Substance: CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg/5mL
DEXCHLORPHENIRAMINE MALEATE	1 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69QQ58998Y	Internal UNII lookup
B10YD955QW	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1369424	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
cf3886ab-62b3-497a-a587-18cbfbaf3634	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
44893bf2-1be4-4e68-8bc4-bbb0f543085e	Product name	1	20180830
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58809-999-01	VANACOF	473 mL in 1 BOTTLE	LIQUID	473	13
58809-999-02	VANACOF	15 mL in 1 BOTTLE	LIQUID	15	13
58809-999-02	VANACOF	12 in 1 TRAY	LIQUID	12	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-999-01	ML - Milliliter	58809-999	f1892b11-ba56-471b-be81-1ea3324a93a2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlophedianol Hydrochloride	ACTIVE INGREDIENT	69QQ58998Y	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Dexchlorpheniramine Maleate	ACTIVE INGREDIENT	B10YD955QW	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Chlophedianol	ACTIVE MOIETY	42C50P12AP	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Dexchlorpheniramine	ACTIVE MOIETY	3Q9Q0B929N	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Sorbitol	INACTIVE INGREDIENT	506T60A25R	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-999	VANACOF (CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]	12	Current NDC, Legacy NDC, 3 package rows	20240502_cf3886ab-62b3-497a-a587-18cbfbaf3634.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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645	2025-05-07	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	2b962d87-6ff5-4c0f-8504-e5b61c940612	2025-05-05	Warnings	Exact identifier application number: M012
Cough and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID	CVS	2d13564a-e8d1-c357-e063-6394a90ad90e	2025-05-02	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Exact identifier application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy, Inc.	2d13964a-8cc4-f3dc-e063-6394a90aa105	2025-05-02	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	AARNA USA INC.	32c26835-f54e-d7e5-e063-6294a90ae1c0	2025-04-30	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	8296049c-72fc-4200-9d45-c8e377314cf2	2025-04-29	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Aurohealth LLC	70e1bd25-c32e-491f-b383-91d6f74957a0	2025-04-28	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	70914691-220c-4fce-9ee1-61a51e8864bc	2025-04-26	Warnings	Exact identifier application number: M012
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	810ce630-41be-4e15-b64a-d70f63abaf62	2025-04-24	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	5f945975-224f-43eb-b129-a61e3b25c4bb	2025-04-22	Warnings	Exact identifier application number: M012
Walgreens Severe Honey Lemon Throat Drops	MENTHOL	Walgreens	334a9348-2a44-5c94-e063-6394a90ae956	2025-04-21	Warnings	Exact identifier application number: M012
meijer Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bd85bc3-e600-583d-e063-6294a90a7be1	2025-04-18	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	KROGER COMPANY	2be4a37b-44e1-8a8e-e063-6394a90a26a9	2025-04-17	Warnings	Exact identifier application number: M012
good neighbor pharmacy childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Amerisource Bergen	cde0fd43-771f-4528-bad2-5727efec5250	2025-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	729ab412-f30b-4ad1-9d8f-1a5e1c48b118	2025-04-16	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9382c976-3067-4923-a38f-101d1c481e97	2025-04-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES	Walmart Inc.	263d31c8-bdc2-a289-e063-6394a90a4aaa	2025-04-10	Warnings	Exact identifier application number: M012
CVS Wild Cherry Throat Drop	PECTIN	CVS	31f4b641-e9c0-786e-e063-6394a90aa253	2025-04-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE
B10YD955QW	DEXCHLORPHENIRAMINE MALEATE	2438-32-6	DEXCHLORPHENIRAMINE MALEATE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1369424	chlophedianol HCl 12.5 MG / dexchlorpheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	cf3886ab-62b3-497a-a587-18cbfbaf3634	13
1369424	chlophedianol hydrochloride 2.5 MG/ML / dexchlorpheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	cf3886ab-62b3-497a-a587-18cbfbaf3634	13
1369424	chlophedianol hydrochloride 12.5 MG / dexchlorpheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution	SY	cf3886ab-62b3-497a-a587-18cbfbaf3634	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-999-01	58809099901	473 mL in 1 BOTTLE (58809-999-01)	473 ml	2008-04-22	0000-00-00	No	No	Current
58809-999-02	58809099902	12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE	12 bottle	2008-04-22	0000-00-00	No	No	Current