FDA.reportPublic FDA data

Virtussin AC

Product NDC
69543-252
Requested package NDC
69543-252-04
11-digit product format
695430252
Labeler code
69543
Product ID
69543-252_53905911-2305-4d4e-ab1a-9aa168361123
Type
HUMAN OTC DRUG
Nonproprietary name
Codeine phosphate and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-07
Marketing end
2023-03-31
Substance
CODEINE PHOSPHATE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69543-25269543-252-04DDiscontinued by firm2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-252-04ML - Milliliter69543-252b8536b74-70ed-422d-9092-ea1739b225ff12015-10-02
69543-252-16ML - Milliliter69543-25211a1b225-86f3-4aa3-847b-f7c5f169acef12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Codeine phosphateACTIVE INGREDIENTGSL05Y1MN6VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
GuaifenesinACTIVE INGREDIENT495W7451VQVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
Codeine anhydrousACTIVE MOIETYUX6OWY2V7JVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
GuaifenesinACTIVE MOIETY495W7451VQVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
potassium citrateINACTIVE INGREDIENTEE90ONI6FFVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
sorbitolINACTIVE INGREDIENT506T60A25RVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RVIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID [VIRTUS PHARMACEUTICALS]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN2ba017d3-1d82-4215-8820-711705540fa42
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2ba017d3-1d82-4215-8820-711705540fa42
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2ba017d3-1d82-4215-8820-711705540fa42
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN1170ffbd-0cb8-40cd-b55f-2ac8004952721
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1170ffbd-0cb8-40cd-b55f-2ac8004952721
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1170ffbd-0cb8-40cd-b55f-2ac8004952721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-252-0469543025204118 mL in 1 BOTTLE (69543-252-04) 118 ml2015-07-072022-10-31NoNoCurrent