NIGHTTIME COLD AND FLU

Product NDC: 0363-1011
11-digit product format: 003631011
Labeler code: 0363
Product ID: 0363-1011_2ceb69d1-a3ea-c3da-e063-6394a90ae9a7
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: WALGREENS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-23
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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	0363-1011-24	`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	0363-1011-24	`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	0363-1011-24	`0efc9e666f02…`	`f202fb6c5f17…`

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
Brand name suffix: Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1297288	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
dbf5c814-4e69-13ac-e053-2a95a90a49a3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-1011-24	2025-02-11	C162847	48780-1	2cef2736-91ae-d83d-e063-dadaa90ab31f	626T Walgreens 0363-1011 NIGHTTIME SEVERE COLD AND FLU 24 ct
0363-1011-24	2025-01-30	C162847	48780-1	2cef2736-91ae-d83d-e063-dadaa90ab31f	626T Walgreens 0363-1011 NIGHTTIME SEVERE COLD AND FLU 24 ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-1011-24	NIGHTTIME COLD AND FLUMaximum Strength	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		3
0363-1011-24	NIGHTTIME COLD AND FLUMaximum Strength	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1011	NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]	3	Current NDC, Legacy NDC, 2 package rows	20250213_dbf5c814-4e69-13ac-e053-2a95a90a49a3.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 69 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Menthol Chewable Gels	MENTHOL	Walmart	1ba4b2be-7242-0a23-e063-6294a90af29c	2025-12-23	Warnings	Exact identifier application number: M012
Walgreens Severe Menthol Throat Drops	MENTHOL	Walgreens	21dd3c68-cbc6-4799-e063-6394a90a6972	2025-12-23	Warnings	Exact identifier application number: M012
cherry throat relief lozenges	BENZOCAINE	Zee Medical	499d0748-538f-678c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	NuCare Pharmaceuticals, Inc.	46a480c7-7092-b809-e063-6294a90a60cd	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	360a6304-206d-5475-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	36342d8c-34ab-6178-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Winco Foods	37244333-1307-5121-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco foods	37718c73-880e-4a5c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco Foods	40676ddc-577f-5cc9-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
Sugar Free Menthol Cough Drops	MENTHOL	Winco Foods	3788e8b6-ab9e-1513-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	eeca6370-29ea-4540-8139-e8461d58a286	2025-12-23	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	dd31f86b-f59e-459a-8e5f-176828706a4a	2025-12-23	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f8e7a08e-7422-4a1b-bfec-93e0b50d10cd	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ae97-7951-4058-e053-2995a90a7b2e	2025-12-23	Warnings	Exact identifier application number: M012
Childrens Chest Congestion Relief Grape	GUAIFENESIN	Discount Drug Mart	3e5d245f-515c-4106-a855-fb97681b646a	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ed16-86bb-3faf-e053-2995a90acfbc	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	a7999da7-148a-4c6d-a2ea-0f4cc1d5b283	2025-12-23	Warnings	Exact identifier application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	279e309c-040d-4001-808d-b7d986a9a1d8	2025-12-23	Warnings	Exact identifier application number: M012
Sinus PE Head Congestion and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	76fd1f8e-2670-421c-a9e6-c8adefb7962e	2025-12-23	Warnings	Exact identifier application number: M012
Leader Cough Drops Vanilla Honey	MENTHOL	Cardinal Health 110, LLC. DBA Leader	1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2	2025-12-22	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2634364	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack	GPCK	da2a77c3-7d0f-157b-e053-2995a90a951a	3
2634364	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack	GPCK	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
2634364	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack	PSN	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
2634364	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack	PSN	da2a77c3-7d0f-157b-e053-2995a90a951a	3
1297288	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	dbf5c814-4e69-13ac-e053-2a95a90a49a3	3
1297288	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1297288	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	da2a77c3-7d0f-157b-e053-2995a90a951a	3
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	da2a77c3-7d0f-157b-e053-2995a90a951a	3
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1297288	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	da2a77c3-7d0f-157b-e053-2995a90a951a	3
1297288	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1297288	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	dbf5c814-4e69-13ac-e053-2a95a90a49a3	3
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	da2a77c3-7d0f-157b-e053-2995a90a951a	3
2634364	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack	SY	da2a77c3-7d0f-157b-e053-2995a90a951a	3
2634364	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack	SY	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1297288	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1297288	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	da2a77c3-7d0f-157b-e053-2995a90a951a	3
1297288	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	dbf5c814-4e69-13ac-e053-2a95a90a49a3	3
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	da2b0276-9ab0-38e6-e053-2a95a90a54d8	3
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	da2a77c3-7d0f-157b-e053-2995a90a951a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1011-24	00363101124	2 BLISTER PACK in 1 CARTON (0363-1011-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2022-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
626T Walgreens 0363-1011 NIGHTTIME SEVERE COLD AND FLU 24 ct	WALGREENS \| TIME CAP LABORATORIES INC. \| MARKSANS PHARMA LIMITED	2025-01-30	HUMAN OTC DRUG LABEL	3
630T Walgreens 0363-0775 Maximum Strength Daytime & Nighttime Cold and Flu	Walgreens \| TIME CAP LABORATORIES INC \| MARKSANS PHARMA LTD	2024-03-19	HUMAN OTC DRUG LABEL	3
627T Walgreens 0363-0746 Daytime Nighttime Severe Cold & Flu	Walgreens \| TIME CAP LABORATORIES INC \| MARKSANS PHARMA LTD	2024-03-19	HUMAN OTC DRUG LABEL	3