Home NDC 50383-062-06 Dextromethorphan HBr and Guaifenesin
Product NDC 50383-062
Requested package NDC 50383-062-06
11-digit product format 503830062
Labeler code 50383
Product ID 50383-062_c9b98014-38e5-4347-b26d-43c4c3aa7da1
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Akorn
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-03-07
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10 mg/5mL; mg/5mL
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 2023-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-062-05 Dextromethorphan HBr and Guaifenesin 10 in 1 TRAY SOLUTION 10 5 50383-062-05 Dextromethorphan HBr and Guaifenesin 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5 50383-062-06 Dextromethorphan HBr and Guaifenesin 4 in 1 CASE SOLUTION 4 5 50383-062-07 Dextromethorphan HBr and Guaifenesin 10 in 1 CASE SOLUTION 10 5 50383-062-07 Dextromethorphan HBr and Guaifenesin 10 in 1 TRAY SOLUTION 10 5 50383-062-10 Dextromethorphan HBr and Guaifenesin 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 5 50383-062-10 Dextromethorphan HBr and Guaifenesin 10 in 1 TRAY SOLUTION 10 5 50383-062-11 Dextromethorphan HBr and Guaifenesin 4 in 1 CASE SOLUTION 4 5 50383-062-12 Dextromethorphan HBr and Guaifenesin 10 in 1 TRAY SOLUTION 10 5 50383-062-12 Dextromethorphan HBr and Guaifenesin 10 in 1 CASE SOLUTION 10 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 HYPROMELLOSE 2910 (4000 MPA.S) INACTIVE INGREDIENT RN3152OP35 DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-062 DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [AKORN] 5 Legacy NDC, 10 package rows 20220309_ed74de02-852a-4dfe-8462-fa22044a2258.zip
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 50383-062-06 50383006206 4 TRAY in 1 CASE (50383-062-06) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-05) > 5 mL in 1 CUP, UNIT-DOSE 4 tray 2012-03-07 0000-00-00 No No Current