Home NDC 52083-648-10 DESGEN DM Tabs
Product NDC 52083-648
Requested package NDC 52083-648-10
11-digit product format 520830648
Labeler code 52083
Product ID 52083-648_d51e9f91-e44f-4c24-9b34-127010d0299d
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler KRAMER NOVIS
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-26
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha-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-Adrenergic Agonist [EPC]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52083-648 52083-648-10 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-648 52083-648-10 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-648-10 DESGEN DM Tabs 100 in 1 BOTTLE, PLASTIC TABLET 100 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-648 DESGEN DM TABS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS] 4 Legacy NDC, 1 package rows 20240105_74a2937d-12d5-4c0b-b237-074b4d7c30b1.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 52083-648-10 52083064810 100 TABLET in 1 BOTTLE, PLASTIC (52083-648-10) 100 tablet 2015-08-26 0000-00-00 No No Current