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 108 of 195 · 3,895 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freegells Cough Drops Honey Lemon 30ct MENTHOL RL Albert & Son Inc. 8114e1a2-728d-4489-a494-f28a5e7d9bb3 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 30ct MENTHOL RL Albert & Son Inc. 0c2e594a-cdf8-4595-bda6-0ebc19ac3850 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 200ct MENTHOL R.L. ALBERT & SON, INC f62b7f75-3275-46c9-880c-64148d0dce59 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL R.L. ALBERT & SON, INC 15917bfb-f660-4a12-bdcc-5b4a96e0e1d0 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL RL Albert & Son Inc. 92c54c53-c8bb-4576-abae-715a2f3878bf 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012 FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS MENTHOL R.L. ALBERT & SON, INC c6b36350-386b-4346-bef0-a37ec11319c0 2025-10-08 Warnings Exact identifier application number: M012 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 3314b174-d5bb-4843-9288-9b9c5fce79d5 2025-10-08 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL CVS Pharmacy 22f55699-4922-4c05-bdf5-5844c7dd3ee5 2025-10-07 Warnings Exact identifier application number: M012 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution DIPHENHYDRAMINE HCL MEDWISE LIFESCIENCES INC. 407b7cbb-7ebd-7b7e-e063-6394a90af501 2025-10-06 Warnings Exact identifier application number: M012 Quality Choice Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc 2025-10-06 Warnings Exact identifier application number: M012 Halls Sugar Free Honey Lemon MENTHOL Mondelez Global LLC 2b19fdd2-8088-47f2-be20-f220a6b825fc 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Childrens Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 40802fb6-c1ec-d7b0-e063-6394a90ab423 2025-10-06 Warnings Exact identifier application number: M012 Giltuss Diabetic DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Dextrum Laboratories, Inc 3f64c81a-bbfc-4575-e063-6294a90a6ed7 2025-10-06 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