Night Time Cold and Flu Relief

Product NDC: 11822-3392
11-digit product format: 118223392
Labeler code: 11822
Product ID: 11822-3392_d35c6583-2bf3-4bd6-a010-76ff8322e9f8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Rite Aid Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-29
Marketing end: 2026-12-29
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 325; 15; 6.25 mg/1; mg/1; mg/1
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
Current FDA listing: Yes

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 · 6 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	11822-3392-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	11822-3392-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	11822-3392-0	`bd6a592717d7…`	`303034d00443…`

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: Night Time Cold and Flu Relief
Brand name suffix: Multi Symptom

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094549	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
5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11822-3392-0	2023-02-22	C162847	48780-1	d6a99b39-c6a4-a426-e053-dadaa90af4c2	Drug Facts
11822-3392-0	2022-01-28	C162847	48780-1	d6a99b39-c6a4-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-3392-0	Night Time Cold and Flu ReliefMulti Symptom	48 in 1 CARTON	CAPSULE, LIQUID FILLED	48		4
11822-3392-0	Night Time Cold and Flu ReliefMulti Symptom	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-3392	NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]	3	Current NDC, Legacy NDC, 2 package rows	20240510_5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0.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 55 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S2	RACEPINEPHRINE HYDROCHLORIDE	Nephron Pharmaceuticals Corporation	dd1b35c7-b23b-4b95-8162-df3d263fe32e	2026-01-26	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0d97c634-0975-42d5-8ade-2ed2018cfe9d	2026-01-26	Warnings	Exact identifier application number: M012
GOOD SENSE NIGHT TIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	L. Perrigo Company	cd68289b-3850-40c6-9439-aae0e2d7637d	2026-01-26	Warnings	Exact identifier application number: M012
Seacall Nasal Spray.	NASAL SPRAY	Guangdong Quadrant Ecological Technology Co., Ltd.	1f12618b-7461-fb47-e063-6294a90af753	2026-01-23	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ecf7d210-102c-4053-81f6-67116de6cf7b	2026-01-23	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	44f9255b-0bf9-4573-ac9c-410acb515bc2	2026-01-23	Warnings	Exact identifier application number: M012
Daytime cold and flu non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Meijer Distribution Inc	29caa3a7-7fe6-4134-a9b0-49bdb9280ca7	2026-01-23	Warnings	Exact identifier application number: M012
good neighbor pharmacy night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7	2026-01-23	Warnings	Exact identifier application number: M012
RAYO ACTIVE ICE	MENTHOL, CAMPHOR	Quimicas Handal de Centroamerica SA de CV	09e4a36b-020a-c5b1-e063-6394a90a3e31	2026-01-22	Warnings	Exact identifier application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc.	f466fc0e-3384-4884-832e-99bf1fdcf899	2026-01-21	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR GUAIFENESIN	Strategic Sourcing Services LLC	84750bfb-9e94-40a3-b731-21799f5e4fd1	2026-01-20	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Amerisource Bergen	0b58990f-2246-408e-9365-51f56bb6766c	2026-01-20	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	a8460fc9-2d08-4e5f-8dd3-5135ecda5923	2026-01-20	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Family Dollar Services Inc	0a651316-623e-41eb-ab3a-641f5d807425	2026-01-20	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu	WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU	Walgreens	579c47c8-6366-4785-9680-d3986ce9641d	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold	WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD	Walgreens	dd61c9d3-0b70-450e-9525-282710b383cc	2026-01-19	Warnings	Exact identifier application number: M012
Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	48bf7422-38ef-d4b4-e063-6294a90aa3ab	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	fc670515-a820-4ea7-8786-8ae710798b31	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	WALGREENS	9dece7b1-00b1-2499-e053-2a95a90a0be3	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	2dba2bec-e0e3-4910-89c5-ebc093e05bec	2026-01-19	Warnings	Exact identifier application number: M012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	4
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	4
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-3392-0	11822339200	48 BLISTER PACK in 1 CARTON (11822-3392-0) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	48 blister pack	2020-05-29	2026-12-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Rite Aid Corporation	2025-12-30	HUMAN OTC DRUG LABEL	8
Drug Facts	Rite Aid Corporation	2025-08-18	HUMAN OTC DRUG LABEL	4