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 92 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGH	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	TARGET CORPORATION	05ac2a40-5eee-4013-b55b-6e370a28b21c	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENs COLD and COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	eb912834-1b14-484d-90f7-a8deb52c0d4e	2025-11-05	Warnings	Exact identifier application number: M012
UP and UP Daytime Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	a2d99bc8-7295-4922-acff-0cb02c91273c	2025-11-05	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	AMERISOURCE BERGEN	c1843f1a-ae5b-0fdf-e053-2995a90aae38	2025-11-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4754363d-e163-42e0-a65d-1c4bac24f6c9	2025-11-05	Warnings	Exact identifier application number: M012
Day Time Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Safeway, Inc.	76d62892-615d-4744-95aa-3be1207a0e57	2025-11-05	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway, Inc.	6fefff08-13b0-47eb-aa32-8d7e4deeae7b	2025-11-05	Warnings	Exact identifier application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ct	MENTHOL	R.L. ALBERT & SON, INC	165a8efa-2b03-4329-99fa-3233f0af7d08	2025-11-04	Warnings	Exact identifier application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ct	MENTHOL	R.L. ALBERT & SON, INC	f9ea46fc-0b04-444e-95fc-09aff7e7978a	2025-11-04	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40413cdb-68ac-70e1-e063-6394a90a9217	2025-11-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	73fec783-1594-447b-b059-49ea9dbb5bee	2025-11-04	Warnings	Exact identifier application number: M012
Texaclear Fast Acting Allergy Relief	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	17a2f643-fa98-21ee-e054-00144ff88e88	2025-11-03	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e618bc7-0f51-e586-e063-6294a90afe37	2025-11-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e61b5b3-ad15-01bf-e063-6394a90a6ec3	2025-11-03	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	409540c0-1bab-9969-e063-6394a90a47c1	2025-11-03	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e60b340-bd60-9318-e063-6294a90ad079	2025-11-03	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e60e32f-3e5f-b775-e063-6294a90a097d	2025-11-03	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e614265-b35a-5d01-e063-6294a90aad85	2025-11-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e60b0ed-889d-0f17-e063-6394a90a4694	2025-11-03	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