Home NDC 58809-555-08 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.
DailyMed Product Concepts# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 79 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cherry Sore Throat Lozenge BENZOCAINE American Sales 49248a40-1ca3-6dd1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL American Sales 4896cbd1-57dd-1fc6-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Cintas Corporation 49b25e9e-1d47-4a10-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry sore throat lozenge BENZOCAINE CVS Pharmacy 3c54974d-9d15-2fa1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 honey lemon sore throat lozenges BENZOCAINE CVS Pharmacy 3c55009c-4b3e-135e-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL CVS Pharmacy 3bdd24a8-3b44-00cd-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL CVS Pharmacy 3c125b3a-e58f-5c06-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 CVS Menthol Cough Drops MENTHOL CVS Pharmacy de97d13b-bb67-d0e6-e053-2995a90aeb2c 2025-12-07 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL American Sales 34dd34d1-1a08-3470-e054-00144ff8d46c 2025-12-06 Warnings Exact identifier application number: M012 DOLOGEN ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE Kramer Novis 656ea9ba-c9cf-44c6-af40-b8ba292ce38a 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC a79b5541-864b-412a-a085-96986ed6af59 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 346f32cb-74cb-4896-b770-76d5f829a17d 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Original Pump Mist OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 530b2d27-5883-489e-87fa-90b45eb93b3c 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE Bayer HealthCare LLC. ee666963-e686-4374-b52b-a677f1cd4114 2025-12-05 Warnings Exact identifier application number: M012 Afrin No-Drip Allergy Sinus OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC 3beb5839-7422-449d-e054-00144ff88e88 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Nighttime Multi-Symptom Cold ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE Bayer HealthCare LLC. 513ca24f-1262-4a2d-e054-00144ff8d46c 2025-12-05 Warnings Exact identifier application number: M012 Afrin Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. a49a506e-aca2-4af0-a50b-dca2c031e61d 2025-12-05 Warnings Exact identifier application number: M012 Throat Coat Sweet Orange Fennel MENTHOL Traditional Medicinals, Inc. a746cef4-1fb4-45cf-e053-2995a90a02c8 2025-12-05 Warnings Exact identifier application number: M012 Guaifenesin GUAIFENESIN Health Pharma USA LLC 31755594-3e1c-b290-e063-6394a90aba61 2025-12-05 Warnings Exact identifier application number: M012 Tabcin Extra Strength ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, Pharmadel LLC 0670c33e-8a3c-ae00-e063-6294a90a165b 2025-12-05 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# 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