Nighttime Cold and Flu Relief

Product NDC: 69256-899
11-digit product format: 692560899
Labeler code: 69256
Product ID: 69256-899_e277dc8a-2ac2-4216-955f-3723cd2d4658
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Harris Teeter, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-05-28
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Nighttime Cold and Flu Relief
Listing expiration: 2027-12-31

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
89fd57d2-fe49-41cb-b02e-9643e526cf47	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69256-899-24	Nighttime Cold and Flu Relief	24 in 1 CARTON	CAPSULE, LIQUID FILLED	24		5
69256-899-24	Nighttime Cold and Flu Relief	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69256-899	NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HARRIS TEETER, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240411_89fd57d2-fe49-41cb-b02e-9643e526cf47.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 54 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	1d6c23d7-d1dc-4cba-8600-5762c18a0e27	2026-01-29	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Belmora LLC	3622e072-2784-c57e-e063-6394a90a8217	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M012
Night Time Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	e7dd763b-3005-4723-933b-171eb772afee	2026-01-29	Warnings	Exact identifier application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	24bc9ae6-8e8f-c0a0-e063-6394a90a407f	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	229d1939-84a9-f18e-e063-6394a90aba30	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1fcbafaa-c871-db6d-e063-6394a90aab5e	2026-01-28	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	1f7a6375-ab66-9782-e063-6394a90a99f3	2026-01-28	Warnings	Exact identifier application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	MEDWISE LIFESCIENCES INC.	4970b8bc-3c7b-4b8a-e063-6294a90a7f1b	2026-01-28	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	fe3e74ba-31d9-4d50-ab61-ffb6aaa66085	2026-01-28	Warnings	Exact identifier application number: M012
Leader Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. dba Leader	9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5	2026-01-28	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	93d5b1db-e9ad-4a6a-b869-fd0d1a11df02	2026-01-27	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	53a3e6a7-d625-4393-95eb-bb6f86e86cc1	2026-01-27	Warnings	Exact identifier application number: M012
Dextromethorphan Hbr,Guaifenesin	DEXTROMETHORPHAN HBR,GUAIFENESIN	SOFTGEL HEALTHCARE PRIVATE LIMITED	2fbbfc7c-81a9-b647-e063-6394a90a55ac	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	32074a31-326b-4aaf-e063-6394a90a0d40	2026-01-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	335b6ddd-fdc8-1120-e063-6394a90add41	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	37e8ccd5-6be1-9aca-e063-6394a90a5263	2026-01-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	SOFTGEL HEALTHCARE PRIVATE LIMITED	2f7f078e-de04-9d53-e063-6394a90a409f	2026-01-27	Warnings	Exact identifier application number: M012
Sunscreen SPF50	NON NANO ZINC OXIDE	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI	c5d52f13-a649-9579-e053-2a95a90a062c	2026-01-27	Warnings	Exact identifier application number: M012
XL-3 Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rnv LLC	03210929-331e-462d-b566-4e1865f52246	2026-01-27	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Rnv LLC	2381ff41-4584-4b38-839f-f94e733f5bf2	2026-01-27	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	89fd57d2-fe49-41cb-b02e-9643e526cf47	5
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	89fd57d2-fe49-41cb-b02e-9643e526cf47	5
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	89fd57d2-fe49-41cb-b02e-9643e526cf47	5
2634564	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack	GPCK	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	PSN	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	SY	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69256-899-24	69256089924	24 BLISTER PACK in 1 CARTON (69256-899-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	24 blister pack	2021-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Safeway Nighttime Cold & Flu	Harris Teeter, LLC	2025-12-22	HUMAN OTC DRUG LABEL	5
DRUG FACTS	Harris Teeter, LLC	2025-09-12	HUMAN OTC DRUG LABEL	4