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 85 of 195 · 3,895 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join sugar free menthol cough drops MENTHOL CVS Pharmacy 3bdd24a8-3b44-00cd-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL CVS Pharmacy 3c125b3a-e58f-5c06-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 CVS Menthol Cough Drops MENTHOL CVS Pharmacy de97d13b-bb67-d0e6-e053-2995a90aeb2c 2025-12-07 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL American Sales 34dd34d1-1a08-3470-e054-00144ff8d46c 2025-12-06 Warnings Exact identifier application number: M012 DOLOGEN ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE Kramer Novis 656ea9ba-c9cf-44c6-af40-b8ba292ce38a 2025-12-05 Warnings Exact identifier application number: M012 Vicks NyQuil HOT REMEDY Cold and Flu ACETAMINOPHEN, DIPHENHYDRAMINE HCL Procter & Gamble Manufactura S de RL de CV 4535d4fe-9de7-f2c6-e063-6394a90a944a 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC a79b5541-864b-412a-a085-96986ed6af59 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 346f32cb-74cb-4896-b770-76d5f829a17d 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Original Pump Mist OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 530b2d27-5883-489e-87fa-90b45eb93b3c 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE Bayer HealthCare LLC. ee666963-e686-4374-b52b-a677f1cd4114 2025-12-05 Warnings Exact identifier application number: M012 Afrin No-Drip Allergy Sinus OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC 3beb5839-7422-449d-e054-00144ff88e88 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Nighttime Multi-Symptom Cold ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE Bayer HealthCare LLC. 513ca24f-1262-4a2d-e054-00144ff8d46c 2025-12-05 Warnings Exact identifier application number: M012 Afrin Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. a49a506e-aca2-4af0-a50b-dca2c031e61d 2025-12-05 Warnings Exact identifier application number: M012 Throat Coat Sweet Orange Fennel MENTHOL Traditional Medicinals, Inc. a746cef4-1fb4-45cf-e053-2995a90a02c8 2025-12-05 Warnings Exact identifier application number: M012 Guaifenesin GUAIFENESIN Health Pharma USA LLC 31755594-3e1c-b290-e063-6394a90aba61 2025-12-05 Warnings Exact identifier application number: M012 Tabcin Extra Strength ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, Pharmadel LLC 0670c33e-8a3c-ae00-e063-6294a90a165b 2025-12-05 Warnings Exact identifier application number: M012 Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE Shield Pharmaceuticals Corp d0dd4a75-da65-4c66-b65f-54ee14100846 2025-12-05 Warnings Exact identifier application number: M012 Basic Care Cherry Cough Drops MENTHOL Amazon.com c0588221-0c84-66d8-e053-2995a90a874f 2025-12-05 Warnings Exact identifier application number: M012 Basic Care Honey Lemon Cough Drops MENTHOL Amazon.com c0937b13-f679-a764-e053-2a95a90abf89 2025-12-05 Warnings Exact identifier application number: M012 Basic Care SF Menthol Cough Drops MENTHOL Amazon.com c0946295-7cf0-1bd8-e053-2a95a90af5af 2025-12-05 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