Home NDC 69543-253-04 VIRTUSSIN DAC
Product NDC 69543-253
Requested package NDC 69543-253-04
11-digit product format 695430253
Labeler code 69543
Product ID 69543-253_36f52bd0-64fc-4330-b625-6fc9bb414a15
Type HUMAN OTC DRUG
Nonproprietary name codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Virtus Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-01-31
Marketing end 2022-11-30
Substance CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC], alpha-Adrenergic Agonist [EPC]
DEA schedule CV
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Codeine phosphate ACTIVE INGREDIENT GSL05Y1MN6 VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Pseudoephedrine Hydrochloride ACTIVE INGREDIENT 6V9V2RYJ8N VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Codeine Anhydrous ACTIVE MOIETY UX6OWY2V7J VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Pseudoephedrine ACTIVE MOIETY 7CUC9DDI9F VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 Alcohol INACTIVE INGREDIENT 3K9958V90M VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 potassium citrate INACTIVE INGREDIENT EE90ONI6FF VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 sorbitol INACTIVE INGREDIENT 506T60A25R VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1 water INACTIVE INGREDIENT 059QF0KO0R VIRTUSSIN DAC (CODEINE PHOSPHATE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [VIRTUS PHARMACEUTICALS] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69543-253-04 69543025304 118 mL in 1 BOTTLE (69543-253-04) 118 ml 2019-01-31 2022-11-30 No No Current