VANACOF DM

Product NDC: 58809-555
11-digit product format: 588090555
Labeler code: 58809
Product ID: 58809-555_42b78046-7cf6-3ab7-e063-6394a90a67a6
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: GM Pharmaceuticals, INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 18; 200; 10 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 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 DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	18 mg/15mL
GUAIFENESIN	200 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1429362	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
2ed699f2-d004-4fa9-8042-6c85a9ff69b6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-555-08	VANACOF DM	240 mL in 1 BOTTLE	LIQUID	240		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-555-08	ML - Milliliter	58809-555	e43cfae4-922f-4bfc-8c39-532a17f8e6c3	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS,INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-555	VANACOF DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]	10	Current NDC, Legacy NDC, 1 package rows	20250322_2ed699f2-d004-4fa9-8042-6c85a9ff69b6.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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	51e34704-5e6b-4e80-836c-ddbc24a451b2	2026-03-06	Warnings	Exact identifier application number: M012
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Sportpharm LLC	7f4e8d37-8c6b-4849-b86c-4335a0bcac1c	2026-03-06	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu Kit	DAYTIME AND NIGHTTIME COLD AND FLU KIT	Allegiant Health	0533db78-7809-46ea-9998-deb5f6f1d0d9	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Better Living Brands, LLC	0153294d-7f52-4d92-8db8-daeca3e29a3b	2026-03-06	Warnings	Exact identifier application number: M012
Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution, Inc.	87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e	2026-03-06	Warnings	Exact identifier application number: M012
RYNEX PE	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	EDWARDS PHARMACEUTICALS, INC.	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	2026-03-05	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	042f9449-4af0-4b15-bb3e-236afeb1e11f	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Amerisource Bergen	087a3a0b-8d3f-45ed-8807-0af47b446cac	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	NUVICARE LLC	6c4bc7d1-09d9-4311-8457-a1d47ab02a5a	2026-03-05	Warnings	Exact identifier application number: M012
Allergy Relief childrens	DIPHENHYDRAMINE HCL	WALMART INC.	dceb99a9-4aa3-4acc-b632-9a4ba8c87919	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMAZON.COM SERVICES LLC	26101105-a6cf-4b51-a639-9d078542fea3	2026-03-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	3a976e90-c6af-4414-984e-9987158c9e98	2026-03-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	714e93ec-0aa9-4be2-9311-399e82f148e0	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	d1131759-dd2e-4c06-bb73-92dd975f5511	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AMAZON.COM SERVICES LLC	6bbe8cc9-7a60-4476-b5cf-b13c5bebff26	2026-03-04	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5a1dfaf3-370d-4ac7-a72d-a48863a35741	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1429362	dextromethorphan HBr 18 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 15 mL Oral Solution	PSN	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	13
1429362	dextromethorphan hydrobromide 1.2 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.667 MG/ML Oral Solution	SCD	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	13
1429362	dextromethorphan hydrobromide 18 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG per 15 ML Oral Solution	SY	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-555-08	58809055508	240 mL in 1 BOTTLE (58809-555-08)	240 ml	2013-06-01	0000-00-00	No	No	Current