COLD and FLU Nighttime Relief

Product NDC: 55315-357
11-digit product format: 553150357
Labeler code: 55315
Product ID: 55315-357_c1e0a501-8d63-490c-a3c3-b31baa57cd07
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr
Dosage form: SOLUTION
Route: ORAL
Labeler: Fred's, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-08-24
Marketing end: 2021-10-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55315-357		D	Discontinued by firm		2026-10-20
excluded package	package	55315-357	55315-357-31	D	Discontinued by firm		2026-10-20

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 · 24 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	55315-357-31	`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	55315-357-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55315-357-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55315-357-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55315-357-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55315-357-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55315-357-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55315-357-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55315-357-31	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55315-357-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55315-357-31	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55315-357-31	`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
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
ANISE	INACTIVE INGREDIENT	21C2F5E8RE	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [FRED'S, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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
55315-357-31	55315035731	2 BOTTLE in 1 CARTON (55315-357-31) > 355 mL in 1 BOTTLE	2 bottle	2015-08-24	2021-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLD and FLU Nighttime Relief - Fred's, Inc. \| Aurohealth LLC	Fred's, Inc. \| Aurohealth LLC	2020-11-26	Human OTC Drug Label	4

COLD and FLU Nighttime Relief

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#