VANACOF DM

Product NDC: 58809-555
Requested package NDC: 58809-555-08
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 116 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Nighttime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS	WALGREENS	2be0a699-e6ad-ef56-e063-6394a90aaca5	2025-04-03	Warnings	Exact identifier application number: M012
Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	44fb27d3-5125-4511-84d2-76555bc46e66	2025-04-03	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	31b8ad0a-3637-03db-e063-6394a90acdc3	2025-04-01	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	31aa54d8-df8d-f1ae-e063-6294a90a9622	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Exact identifier application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	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