Cough Relief

Product NDC: 36800-509
11-digit product format: 368000509
Labeler code: 36800
Product ID: 36800-509_931fb6be-5864-4a3e-b62a-5566990fa0cc
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr
Dosage form: LIQUID
Route: ORAL
Labeler: TOP CARE (Topco Associates LLC)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-03-31
Marketing end: 2026-11-28
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 15 mg/5mL
Pharmacologic classes: 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
Current FDA listing: Yes

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: Cough Relief
Brand name suffix: Adult

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090496	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
b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-509-04	Cough ReliefAdult	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		8
36800-509-04	Cough ReliefAdult	1 in 1 BOX	LIQUID	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-509	COUGH RELIEF ADULT (DEXTROMETHORPHAN HBR) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]	7	Current NDC, Legacy NDC, 2 package rows	20240616_b2ebfeb3-e248-40bf-81d3-81c5fb532dbe.zip

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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	50762d7c-5efd-4f83-e063-6294a90abf7f	2026-04-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	6427b418-89d1-4eac-b25b-0adfefc204fc	2026-04-27	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier application number: M012
Leader Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	333c7042-95b8-4d98-9df1-4287017afa36	2026-04-25	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f2d55d1b-c3d4-4c35-b761-681ed50273bd	2026-04-24	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Sportpharm LLC	2c4e0d5e-958d-4274-876a-52126c795c0f	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50364a42-3333-51fe-e063-6394a90ab71e	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5036dc50-e95b-ea8d-e063-6394a90a6cfe	2026-04-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dcb33d5f-87fa-4043-9b6d-36adec96796c	2026-04-24	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Cardinal Health 107, LLC	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	2026-04-23	Warnings	Exact identifier application number: M012
nitetime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	c5535aaf-c029-48d8-97d1-105a49b5fd95	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	50228b3c-d54a-485d-e063-6394a90a4403	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5025a333-6378-bf59-e063-6394a90af4f0	2026-04-23	Warnings	Exact identifier application number: M012
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	POLY PHARMACEUTICALS, INC.	5025c99f-b946-e2e0-e063-6394a90a13fb	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5026611c-93e7-8f90-e063-6394a90a7baa	2026-04-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	COSTCO WHOLESALE CORPORATION	5180abbc-c6c4-4b82-b6e7-4504e3bcff0f	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	4f963491-e1f0-494d-acb6-5f4d2b267d4a	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	f4b01827-7444-3bfc-e053-2a95a90aebed	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	cfd43b8f-8064-6b88-e053-2a95a90a329e	2026-04-22	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090496	dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	8
1090496	dextromethorphan hydrobromide 3 MG/ML Oral Solution	SCD	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	8
1090496	dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution	SY	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	8
1090496	dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution	SY	b2ebfeb3-e248-40bf-81d3-81c5fb532dbe	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-509-04	36800050904	1 BOTTLE, PLASTIC in 1 BOX (36800-509-04) / 118 mL in 1 BOTTLE, PLASTIC	2016-03-31	2026-11-28	No	No	Current