Home NDC 53145-039 Defensol Adult Syrup
Product NDC 53145-039
11-digit product format 531450039
Labeler code 53145
Product ID 53145-039_3a89a0df-993d-f0d7-e063-6394a90a1c8b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan HBR
Dosage form LIQUID
Route ORAL
Labeler Menper Distributors, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 20 mg/10mL; mg/10mL
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 2027-12-31
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 · 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53145-039 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-039 53145-039-04 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Defensol Adult Syrup
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH 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 53145-039-04 Defensol Adult Syrup 1 in 1 CARTON LIQUID 1 6 53145-039-04 Defensol Adult Syrup 120 mL in 1 BOTTLE LIQUID 120 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.] 2
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 97 of 178 · 3,551 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 53145-039-04 53145003904 1 BOTTLE in 1 CARTON (53145-039-04) / 120 mL in 1 BOTTLE 1 bottle 2012-02-21 0000-00-00 No No Current