Home NDC 53145-059-02 Cosedal Drops
Product NDC 53145-059
Requested package NDC 53145-059-02
11-digit product format 531450059
Labeler code 53145
Product ID 53145-059_3a8a3022-d085-1ccf-e063-6394a90a90ed
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBR, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Menper Distributors, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 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 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 · 3 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-059 53145-059-02 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-059 53145-059-02 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-059 53145-059-02 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 Cosedal Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/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 53145-059-02 Cosedal Drops 60 mL in 1 BOTTLE, DROPPER LIQUID 60 6 53145-059-02 Cosedal Drops 1 in 1 CARTON LIQUID 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] 3
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 179 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mucus Relief DM MUCUS RELIEF DM TopCo Associates, LLC 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 2022-06-07 Warnings Exact identifier application number: M012 Daytime Nighttime Cold and Flu Relief Combo Pack DAYTIME NIGHTTIME COLD AND FLU Allegiant Health fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 2022-05-19 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Good Sense 26a199bf-57e5-4f36-b40c-83a1187e4870 2022-05-18 Warnings Exact identifier application number: M012 Mucus Relief DM Immediate Release MUCUS RELIEF DM Allegiant Health 731f8608-ad5b-491e-a4d4-2bb0c423fed5 2022-05-18 Warnings Exact identifier application number: M012 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL OPMX LLC b3c229a4-c772-70fb-e053-2a95a90a72db 2022-03-11 Warnings Exact identifier application number: M012 Allergy Relief CHLORPHENIRAMINE MALEATE Good Sense f88e2654-8e97-4cf6-9c36-01aeb51a9102 2021-11-30 Warnings Exact identifier application number: M012 Cold Medicine COLD MEDICINE Allegiant Health 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 2021-11-23 Warnings Exact identifier application number: M012 Decongestant PE Non Drowsy PHENYLEPHRINE HCL Allegiant Health 7a3098b4-381c-4f32-97a7-87b53fd64428 2021-06-16 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG Good Sense e7c68746-7ec0-46cf-b4a3-174fab819b5e 2021-05-05 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN 400MG TopCo Associates, LLC 7d91c6ab-d161-42b9-b353-0aa8f59619f8 2021-01-21 Warnings Exact identifier application number: M012 Daytime Cold and Flu ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG Allegiant Health bed5f9dc-45ea-4e90-86c6-86599b6f3861 2020-11-16 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN Allegiant Health b97126d7-847d-483e-b3d1-e2b61ab1743f 2020-11-11 Warnings Exact identifier application number: M012 Cold and Allergy PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE Allegiant Health 7af63769-fa56-4f1f-a2ad-5b4c108c8e4f 2019-12-12 Warnings Exact identifier application number: M012 Mucus Relief Immediate Release GUAIFENESIN Allegiant Health 221d64a2-b8c7-435a-aae4-fb58fd38108f 2019-03-26 Warnings Exact identifier application number: M012 Sleep Tabs For Nighttime use DIPHENHYDRAMINE HCL TABLETS Allegiant Health 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d 2018-12-26 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Allegiant Health 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 2018-12-26 Warnings Exact identifier application number: M012 Sleep Aid DIPHENHYDRAMINE HCL 25 MG Allegiant Health dbbc535f-515a-4d9b-b799-34e60f5230bb 2018-12-21 Warnings Exact identifier application number: M012 Allergy DIPHENHYDRAMINE HCL Allegiant Health c2823bad-540f-4662-8dcc-58e9f0d94efb 2018-11-07 Warnings Exact identifier application number: M012 Nasal Decongestant PE Maximum Strength Non-Drowsy PHENYLEPHRINE 10 MG Allegiant Health 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 2018-11-07 Warnings Exact identifier application number: M012 DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-059-02 53145005902 1 BOTTLE, DROPPER in 1 CARTON (53145-059-02) / 60 mL in 1 BOTTLE, DROPPER 2012-02-21 0000-00-00 No No Current