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 135 of 195 · 3,895 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vapor Shower MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 8095b211-8ae7-44e5-b89a-b7f730e28d51 2025-01-30 Warnings Exact identifier application number: M012 Vapor Shower MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2cf2f35b-5d59-e3ff-e063-6294a90a9b45 2025-01-30 Warnings Exact identifier application number: M012 Sinus Congestion and Pain Relief Non-Drowsy, Daytime ACETAMINOPHEN AND PHENYLEPHRINE HCL Rite Aid Corporation 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5 2025-01-30 Warnings Exact identifier application number: M012 Mucinex Childrens Mighty Chews Cold and Flu ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE RB Health (US) LLC 2ce20ab5-5f2d-1c97-e063-6394a90ad67b 2025-01-29 Warnings Exact identifier application number: M012 Guaifenesin and Dextromethorphan GUAIFENESIN AND DEXTROMETHORPHAN Major Pharmaceuticals 97b137c9-0bec-409a-91f7-e298c296578b 2025-01-29 Warnings Exact identifier application number: M012 Childrens Mucus and Cough Relief DEXTROMETHORPHAN HBR, GUAIFENESIN CVS 1dc17665-62ce-f7f5-e063-6294a90af851 2025-01-29 Warnings Exact identifier application number: M012 UP AND UP NO DRIP NASAL OXYMETAZOLINE HYDROCHLORIDE Target Corporation 760d6d0f-00fc-40bc-858d-83a0827d139f 2025-01-29 Warnings Exact identifier application number: M012 Guaifenesin and Dextromethorphan GUAIFENESIN AND DEXTROMETHORPHAN Major Pharmaceuticals 51e48201-bb62-4e89-85eb-e4a416f93522 2025-01-29 Warnings Exact identifier application number: M012 Severe Congestion and Cough Max DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Best Choice 8c878e47-94f4-484f-bdd8-6d87ac2440d8 2025-01-28 Warnings Exact identifier application number: M012 Cough and Cold Therapy CAMPHOR, MENTHOL, EUCALYPTUS OIL Everlaan Organics Inc 088be461-7afc-586a-e063-6294a90a700b 2025-01-27 Warnings Exact identifier application number: M012 Cough and Cold Therapy For Kids CAMPHOR, MENTHOL, EUCALYPTUS OIL Everlaan Organics Inc 088df369-114c-db4f-e063-6394a90acfac 2025-01-27 Warnings Exact identifier application number: M012 Menthol Cough Drops MENTHOL Target Corporation Inc. eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a 2025-01-26 Warnings Exact identifier application number: M012 Walgreens Menthol Cough Drops MENTHOL Walgreens 2c62f690-8dfb-d28e-e063-6394a90a45a2 2025-01-23 Warnings Exact identifier application number: M012 Walgreens Cherry Cough Drops MENTHOL Walgreens 2c65d836-e724-50d6-e063-6394a90a0827 2025-01-23 Warnings Exact identifier application number: M012 Walgreens Honey Lemon Cough Drops MENTHOL Walgreens 2c67424c-2fb0-cc15-e063-6394a90a02ca 2025-01-23 Warnings Exact identifier application number: M012 Pharmacys Prescription Analgesic Gel MENTHOL American Consumer Products Corp 6f0725f2-833f-f3a0-e053-2a91aa0a3911 2025-01-23 Warnings Exact identifier application number: M012 Pharmacys Prescription Vapor Rub MENTHOL American Consumer Products Corp 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 2025-01-23 Warnings Exact identifier application number: M012 Childrens Allergy Relief DIPHENHYDRAMINE HCL Best Choice 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d 2025-01-22 Warnings Exact identifier application number: M012 GOOD REMEDIES Allergy Relief SOFTGEL DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 26a02737-2cfd-769f-e063-6394a90af352 2025-01-22 Warnings Exact identifier application number: M012 Pharbechlor CHLORPHENIRAMINE MALEATE 4MG Ulai Health LLC 6a1a5cef-e946-4ba8-9402-557c6adf45f9 2025-01-20 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