CareOne NightTime Cough

Product NDC: 41520-995
11-digit product format: 415200995
Labeler code: 41520
Product ID: 41520-995_6f34b8f1-8723-49ce-8542-69ce0e219c6e
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: American Sales Company
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-05-18
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30 mg/30mL; mg/30mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	41520-995		D	Discontinued by firm	2026-10-15
excluded package	package	41520-995	41520-995-34	D	Discontinued by firm	2026-10-15
excluded package	package	41520-995	41520-995-40	D	Discontinued by firm	2026-10-15

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-995-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-995-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-995-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-995-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-995-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-995-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-995-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-995-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-995-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-995-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41520-995-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41520-995-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41520-995-34	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41520-995-34	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CAREONE NITETIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [AMERICAN SALES COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-995	CAREONE NIGHTTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [AMERICAN SALES COMPANY]	7	Legacy NDC	20241024_df51c4c8-14f5-43b4-b156-cc5a1f9dcf97.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
41520-995-40	41520099540	355 mL in 1 BOTTLE (41520-995-40)	355 ml	2013-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Nighttime Cough Drug Facts	American Sales Company	2024-10-22	HUMAN OTC DRUG LABEL	7