Cough Relief

Product NDC: 68210-4242
Requested package NDC: 68210-4242-6
11-digit product format: 682104242
Labeler code: 68210
Product ID: 68210-4242_f15ed5eb-8546-dc50-e053-2995a90a7325
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HBr
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2023-01-03
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 15 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: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68210-4242	68210-4242-6	I	Inactivated by FDA		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4242-6	Cough Relief	1 in 1 POUCH	CAPSULE, LIQUID FILLED	1		4
68210-4242-6	Cough Relief	60 in 1 POUCH	CAPSULE, LIQUID FILLED	60		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4242	COUGH RELIEF (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	4	Legacy NDC, 2 package rows	20241213_b05ca9da-e3df-4a44-8c5a-602e0c91cd46.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090487	dextromethorphan HBr 15 MG Oral Capsule	PSN	b05ca9da-e3df-4a44-8c5a-602e0c91cd46	4
1090487	dextromethorphan hydrobromide 15 MG Oral Capsule	SCD	b05ca9da-e3df-4a44-8c5a-602e0c91cd46	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4242-6	68210424206	1 POUCH in 1 POUCH (68210-4242-6) > 60 CAPSULE, LIQUID FILLED in 1 POUCH	1 pouch	2023-01-03	0000-00-00	No	No	Current