Home NDC 52083-660 Sorbugen
Product NDC 52083-660
11-digit product format 520830660
Labeler code 52083
Product ID 52083-660_796f9d98-f855-437f-9bca-bb322fa5b063
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, glycerol guaiacolate
Dosage form SYRUP
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-08
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 15; 150 mg/7.5mL; mg/7.5mL
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 2026-12-31
Current FDA listing Yes 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-660-16 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-660-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-660-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-660-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-660-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-660-16 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-660-16 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-660-16 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sorbugen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/7.5mL GUAIFENESIN 150 mg/7.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 52083-660-16 Sorbugen 480 mL in 1 BOTTLE SYRUP 480 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-660 SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS] 6 Current NDC, Legacy NDC, 1 package rows 20221029_a8f2a2d7-0360-45a8-9635-c852f4a7d7ba.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
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 52083-660-16 52083066016 480 mL in 1 BOTTLE (52083-660-16) 480 ml 2014-10-08 0000-00-00 No No Current