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 173 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORP	0b1e230d-4354-bf61-e063-6394a90a2b2f	2023-12-09	Warnings	Exact identifier application number: M012
Phenylephrine HCl Maximum Strength	PHENYLEPHRINE HCL	A-S Medication Solutions	fcb769d0-aa45-48eb-acd0-2247b392f9fe	2023-12-09	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf915af-a016-0a46-e063-6394a90aacf5	2023-12-08	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and Flu	DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI	TARGET Corporation	0bf9c0df-7676-3060-e063-6394a90a16c7	2023-12-08	Warnings	Exact identifier application number: M012
Nazal	NAPHAZOLINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	4d4043f8-5ed3-4027-beb6-687db1308202	2023-12-06	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	8b4557d4-74a0-400f-ad7a-6d31473b3c67	2023-12-06	Warnings	Exact identifier application number: M012
Childrens Plus Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1598e6f8-08ee-4216-a5ab-76cad37b09a7	2023-12-06	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf	2023-12-05	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash Relief	PETROLATUM, ZINC OXIDE	Welmedix LLC	551e6cce-7adc-4e98-baff-2703b83d7526	2023-12-05	Warnings	Exact identifier application number: M012
Stona-S	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1	2023-12-04	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	afc95c82-18da-487b-b4bb-51e0be0378da	2023-12-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	a14643a1-3d91-491a-88d6-22dccde97938	2023-12-04	Warnings	Exact identifier application number: M012
TopCare Day Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	14d53907-a4a2-4a0f-b2d6-33474945f9e1	2023-12-04	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Proficient Rx LP	62934d0f-b23d-4c03-9d60-a7bad41f9b42	2023-12-01	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	b1c849e5-8003-4fd3-811d-6a927523e353	2023-12-01	Warnings	Exact identifier application number: M012
Akin Expectorant Formula Strawberry Banana	GUAIFENESIN	Southern Sales & Service, Inc.	b63b0133-d2da-432b-a154-9e77535bbef9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM Strawberry Banana	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Southern Sales & Service, Inc.	7a81efd8-775d-455e-860f-f3e3b369a0a7	2023-11-29	Warnings	Exact identifier application number: M012
Akin	GUAIFENESIN	Southern Sales & Service, Inc.	bb2c9f21-6765-4286-bd71-de01cdf4c4e9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM	DEXTROMETHORPHAN, GUAIFENESIN	Southern Sales & Service, Inc.	1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a	2023-11-29	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	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