Night Time Cough

Product NDC: 55319-499
Requested package NDC: 55319-499-12
11-digit product format: 553190499
Labeler code: 55319
Product ID: 55319-499_49bdd1e6-2b16-468e-9210-6f09386879b6
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form: LIQUID
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-12-31
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30 mg/30mL; mg/30mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	55319-499	55319-499-12	D	Discontinued by firm		2026-10-12

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-499	55319-499-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-499	55319-499-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-499	55319-499-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-499-12	2023-02-11	C162847	48780-1	d6a99b39-511f-a426-e053-dadaa90af4c2	Drug Facts
55319-499-12	2022-01-28	C162847	48780-1	d6a99b39-511f-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-499	NIGHT TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]	3	Legacy NDC	20230212_2f822595-796e-402d-bb1e-a497fa53c435.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-499-12	55319049912	355 mL in 1 BOTTLE, PLASTIC (55319-499-12)	355 ml	2017-12-31	0000-00-00	No	No	Current