Home NDC 45737-263 Biodesp
Product NDC 45737-263
11-digit product format 457370263
Labeler code 45737
Product ID 45737-263_01e61e17-30cb-4c85-a365-b1d68514c06f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Advanced Generic Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 15 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 45737-263-16 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 45737-263-16 9bebd1f3094a…5416666fcb17…
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 45737-263-16 BiodespDM NF 473 mL in 1 BOTTLE LIQUID 473 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) INACTIVE INGREDIENT R33S7TK2EP BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45737-263 BIODESP DM NF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION] 7 Legacy NDC, 1 package rows 20241222_82528dba-e3e7-416a-935d-7b6324a83f5a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45737-263-16 45737026316 473 mL in 1 BOTTLE (45737-263-16) 473 ml 2015-03-01 0000-00-00 No No Current