Home NDC 53145-059 Cosedal Drops
Product NDC 53145-059
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 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 · 6 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-059-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-059-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-059-02 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Cosedal Drops
Listing expiration 2026-12-31 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 81 of 195 · 3,895 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Medicated Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL Cardinal Health, 110 dba LEADER b7393668-1450-4e85-9793-d400daf39b43 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Cough Drops MENTHOL Geiss, Destin, Dunn c72db7f0-9324-8ed2-e053-2995a90a9868 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn c72e557f-0211-81b9-e053-2995a90a1437 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Benzocaine Lozenges BENZOCAINE Geiss, Destin, Dunn c7404c94-09eb-5cc5-e053-2995a90af021 2025-12-12 Warnings Exact identifier application number: M012 Good Sense SF Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn e11ed21f-6ceb-5908-e053-2995a90aea46 2025-12-12 Warnings Exact identifier application number: M012 Complete Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Belmora LLC a81fc021-9a9f-4cec-a1a6-73e3f983b78d 2025-12-12 Warnings Exact identifier application number: M012 Severe Congestion Relief Maximum Strength Sinus ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Wal-Mart Stores Inc 59918b8b-5c91-468f-834e-66020dc1ae12 2025-12-12 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SALADO SALES INC. 8f66f5bc-7c77-420b-9feb-911c980fbfdc 2025-12-12 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