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…`

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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1241d249-ea3b-4d2b-87ed-835d6a2d286a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-059-02	2023-07-28	C162847	48780-1	9d75b9d1-075f-f424-e053-dadaa90a57ce	Cosedal Drops
53145-059-02	2021-08-09	C162847	48780-1	9d75b9d1-075f-f424-e053-dadaa90a57ce	Cosedal Drops
53145-059-02	2020-01-31	C162847	48780-1	9d75b9d1-075f-f424-e053-dadaa90a57ce	Cosedal Drops

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
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 170 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nasal Decongestant	PSEUDOEPHEDRINE HCL	CVS Pharmacy	bebe5e78-09ba-4d35-9d34-9f5e34341478	2024-09-20	Warnings	Exact identifier application number: M012
equaline nasal	PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	67fdd277-7a7a-4404-8ca2-39802c46405f	2024-09-20	Warnings	Exact identifier application number: M012
equaline tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	8bc7fa7c-d565-48c9-9808-1042c3e9d428	2024-09-20	Warnings	Exact identifier application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	d7fae410-9c1c-4231-9fde-2c51ad3d7e95	2024-09-20	Warnings	Exact identifier application number: M012
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	CVS Pharmacy	8913f6d1-3764-4f9c-8695-b788ef1bbe79	2024-09-19	Warnings	Exact identifier application number: M012
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	89272d2d-5533-4ae8-865b-cb204cec6d65	2024-09-17	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	5791c1c7-f614-4940-a45a-6291742e1e22	2024-09-17	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	2affd44d-2125-4a1f-919c-c082e7644ea8	2024-09-17	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE	Advanced Rx LLC	fa1a4d86-87bb-0c50-e053-6394a90a56e2	2024-09-13	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Advanced Rx LLC	fa1b60b1-49cb-1211-e053-6394a90a0a46	2024-09-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	8db7df1c-46b5-49bd-9002-50b12d58001a	2024-09-13	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1bdd7f8a-93ce-5309-e063-6294a90a91f0	2024-09-12	Warnings	Exact identifier application number: M012
Daytime Cough Congestion Nighttime Cold Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL	KinderFarms, LLC	f2113abf-c1a3-42a6-a25e-e30a31fcad95	2024-09-12	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Exact identifier application number: M012
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Exact identifier application number: M012
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	1241d249-ea3b-4d2b-87ed-835d6a2d286a	6
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	1241d249-ea3b-4d2b-87ed-835d6a2d286a	6
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	1241d249-ea3b-4d2b-87ed-835d6a2d286a	6
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	1241d249-ea3b-4d2b-87ed-835d6a2d286a	6
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	1241d249-ea3b-4d2b-87ed-835d6a2d286a	6

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