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 169 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Sinus Relief Mist	OXYMETAZOLINE SPRAY	Walgreens Company	847f47d9-62b1-49a3-8bb3-9bf275685bd2	2024-02-14	Warnings	Exact identifier application number: M012
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
good sense allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	2cfa69b4-e33f-442a-a6df-b021b041da14	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	Warnings	Exact identifier application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier application number: M012
Theraflu Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	c0689223-5c90-4dbc-bbfa-f94e267504c3	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	a4c56ca0-7785-404b-996d-137cc135f270	2024-01-28	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