Home NDC 24689-123-02 Guaifenesin and Dextromethorphan Hydrobromide
Product NDC 24689-123
Requested package NDC 24689-123-02
11-digit product format 246890123
Labeler code 24689
Product ID 24689-123_f17dcc88-303d-4e1f-e053-2a95a90ae08d
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan Hydrobromide
Dosage form TABLET
Route ORAL
Labeler APNAR PHARMA LP
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-12-30
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/1; mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24689-123 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET [APNAR PHARMA LP] 3 Legacy NDC 20230108_e22b0c01-390f-2743-e053-2995a90aee29.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24689-123-02 24689012302 500 TABLET in 1 BOTTLE (24689-123-02) 500 tablet 2022-12-30 0000-00-00 No No Current