MUCINEX INSTASOOTHE

Product NDC: 72854-267
11-digit product format: 728540267
Labeler code: 72854
Product ID: 72854-267_582c85e6-2982-ef3b-e063-6394a90a383a
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: LOZENGE
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 5 mg/1
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
Listing certified through: 2027-12-31
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: MUCINEX INSTASOOTHE
Brand name suffix: COUGH
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/1

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
1370219	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
0d99237c-0b52-0af6-e063-6394a90aba14	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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72854-267-20	MUCINEX INSTASOOTHECOUGH	1 in 1 POUCH	LOZENGE	1	4
72854-267-20	MUCINEX INSTASOOTHECOUGH	20 in 1 BAG	LOZENGE	20	4
72854-267-40	MUCINEX INSTASOOTHECOUGH	1 in 1 POUCH	LOZENGE	1	4
72854-267-40	MUCINEX INSTASOOTHECOUGH	40 in 1 BAG	LOZENGE	40	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72854-267-20	EA - Each	72854-267	836920bc-7166-46f3-a57b-8497b882522e	1	2024-08-12
72854-267-40	EA - Each	72854-267	15509d01-1596-4932-b9fd-f2627ee5a844	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72854-267	MUCINEX INSTASOOTHE COUGH (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC]	3	Current NDC, 4 package rows	20250410_0d99237c-0b52-0af6-e063-6394a90aba14.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 24 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Runny Nose Childrens Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	TOP CARE (Topco Associates LLC)	6f04bd51-093c-4624-aef3-0145ac387386	2026-06-01	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	694a3116-1b75-42cd-bbcf-d19831c2d796	2026-06-01	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	cf31538c-9eee-4c81-80cb-66eecabf0aff	2026-06-01	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	155e07b3-0a08-3be8-e063-6394a90a7635	2026-05-31	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Nighttime	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	156033ae-b16a-007b-e063-6294a90a7445	2026-05-31	Warnings	Exact identifier application number: M012
Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	ebf8c82d-a653-4c02-893b-61704901acbb	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Amerisource Bergen	934c7b91-3cba-47f0-8efa-77216f3f15c4	2026-05-29	Warnings	Exact identifier application number: M012
Allergy Medicine	DIPHENHYDRAMINE HCL	COSTCO WHOLESALE CORPORATION	d9f03e11-d11f-43ee-8ed0-9e07d1058f66	2026-05-29	Warnings	Exact identifier application number: M012
Cold Childrens, Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d	2026-05-29	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	3598ac5b-29f9-f002-e063-6294a90a62cb	2026-05-28	Warnings	Exact identifier application number: M012
NebuClear MD	RACEPINEPHRINE HYDROCHLORIDE	Blue Echo Care LLC	51badd2f-4a43-3dbe-e063-6294a90a4bd1	2026-05-28	Warnings	Exact identifier application number: M012
Kids Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	a7ab2140-de09-158f-e053-2a95a90a25a0	2026-05-28	Warnings	Exact identifier application number: M012
Kids Multi Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Genexa Inc.	2d918ec8-3098-1d09-e063-6294a90a9e8f	2026-05-28	Warnings	Exact identifier application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Genexa Inc.	213fe898-dace-9a0f-e063-6394a90afd64	2026-05-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Lemon Flavor	MENTHOL	Medical Group Care LLC	556628ab-e233-92fe-e063-6394a90a0090	2026-05-28	Warnings	Exact identifier application number: M012
Sinus Decongestion PE	PHENYLEPHRINE HCL	Kroger Company	68eff734-177e-4999-9126-6b92bb204107	2026-05-28	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	ARMY AND AIR FORCE EXCHANGE SERVICE	ff39084f-ab2f-48ed-ac62-837f7fff2b65	2026-05-28	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Select Consumer Group LLC	52c5fda0-c358-72e8-e063-6394a90a3f68	2026-05-27	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack	DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	16637d54-8049-d3ce-e063-6394a90aafc9	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	00689aa5-ed39-4c9a-92b8-105d2c0e2e15	2026-05-27	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
1370219	dextromethorphan HBr 5 MG Oral Lozenge	PSN	0d99237c-0b52-0af6-e063-6394a90aba14	4
1370219	dextromethorphan hydrobromide 5 MG Oral Lozenge	SCD	0d99237c-0b52-0af6-e063-6394a90aba14	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72854-267-20	72854026720	20 POUCH in 1 BAG (72854-267-20) / 1 LOZENGE in 1 POUCH	20 pouch	2024-04-01	No	No	Current
72854-267-40	72854026740	40 POUCH in 1 BAG (72854-267-40) / 1 LOZENGE in 1 POUCH	40 pouch	2024-04-01	No	No	Current