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 53 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foster and Thrive Cherry Cough Drops	MENTHOL	McKesson	49eefa70-cef9-d7ec-e063-6294a90ac321	2026-02-03	Warnings	Exact identifier application number: M012
Foster and Thrive Honey Lemon Cough Drops	MENTHOL	McKesson	49f13ee3-6bb3-e500-e063-6394a90a152d	2026-02-03	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	63cb19d4-2306-4723-a95e-9d2d8b9eccd0	2026-02-03	Warnings	Exact identifier application number: M012
Foster and Thrive SF Honey Lemon Cough Drops	MENTHOL	McKesson	49f41c30-f806-44ba-e063-6394a90a5a67	2026-02-03	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853	2026-02-03	Warnings	Exact identifier application number: M012
allergy relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f	2026-02-03	Warnings	Exact identifier application number: M012
Cold and Allergy D	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	Walgreen Company	832ac849-7f4a-489a-a704-9d4388a75a71	2026-02-03	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	987f908b-7af7-4705-bfb4-c48d771c380d	2026-02-03	Warnings	Exact identifier application number: M012
tussin dm nighttime max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	HyVee Inc	1f3fb451-84c9-432e-ac67-2694dd66c815	2026-02-03	Warnings	Exact identifier application number: M012
Robafen DM Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Major Pharmaceuticals	7c9660b7-cb00-449b-b65f-aa42d8ce1942	2026-02-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	6b0d261f-fc27-4b34-88b1-cd3d72766760	2026-02-02	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	ebfcb699-3369-4697-9841-44015b1c9808	2026-02-02	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE, MENTHOL	Meijer Distribution Inc.	2f6de590-7cad-25d7-e054-00144ff8d46c	2026-02-02	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat and Cough lozenge	DEXTROMETHORPHAN HYDROBROMIDE	Meijer Distribution, Inc.	304ff4db-201a-60a4-e054-00144ff8d46c	2026-02-02	Warnings	Exact identifier application number: M012
Allergy Relief Plus Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	38d91107-d95c-40f2-a27e-561f951e519d	2026-02-02	Warnings	Exact identifier application number: M012
Tussin Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	HyVee Inc	85252999-3463-45fe-b4a9-7a97960b41b1	2026-02-02	Warnings	Exact identifier application number: M012
Amazon Basics Cherry Cough Drops 30ct	MENTHOL	Amazon	3e74e209-c9c9-3979-e063-6294a90afcfa	2026-02-01	Warnings	Exact identifier application number: M012
Amazon Basics Honey Lemon Cough Drops 30ct	MENTHOL	Amazon	3e75838b-e1c9-2d42-e063-6294a90aab82	2026-02-01	Warnings	Exact identifier application number: M012
cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	5110526f-51fd-401e-ba52-520674d34f37	2026-02-01	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Amazon.com Service LLC	673996ab-6e57-4feb-8af3-d8b474741a8d	2026-01-30	Warnings, Adverse reactions	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