Cold and Flu

Product NDC: 0363-9012
11-digit product format: 003639012
Labeler code: 0363
Product ID: 0363-9012_48c126ee-83f4-680a-e063-6394a90ac8bb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form: KIT
Labeler: Walgreens
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-08-24
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-9012-48	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-9012-48	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-9012-48	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-9012-48	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-9012-48	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-9012-48	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-9012-48	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-9012-48	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-9012-48	U	Excluded because listing certification expired	`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: Cold and Flu
Brand name suffix: Daytime, Nighttime, Multi-Symptom
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1086997	Internal RxNorm lookup
1094549	Internal RxNorm lookup
2634564	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
fc670515-a820-4ea7-8786-8ae710798b31	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2026-01-19	Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu
2025-01-30	Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu
2023-12-11	Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu
2023-01-30	Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-9012-48	Cold and FluDaytime, Nighttime, Multi-Symptom	1 in 1 PACKAGE, COMBINATION	KIT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9012	COLD AND FLU DAYTIME, NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREENS]	4	Current NDC, Legacy NDC, 1 package rows	20231212_fc670515-a820-4ea7-8786-8ae710798b31.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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus and Headache Daytime	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	869e950c-5861-4840-aaad-b0342790d62b	2026-02-10	Warnings	Exact identifier application number: M012
CareOne Night TIme Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25	2026-02-10	Warnings	Exact identifier application number: M012
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Sportpharm LLC	d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	f3fc270a-92fc-46d5-b187-44e875c3abb9	2026-02-09	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	d5c8b248-6d82-4eac-881c-0b9d0a0de8f1	2026-02-09	Warnings	Exact identifier application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	d07112dd-27df-46cc-b7c3-af8ba7601d06	2026-02-09	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	48f7933e-6582-638c-e063-6394a90abfe5	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Retail Business Services, LLC	4fb46860-2bf9-41a7-89eb-31c259c61107	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Sportpharm LLC	909dacfa-50d3-4bcf-b2df-5405427cfaad	2026-02-06	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f91b7c1f-e074-4767-b9c8-dbf1937a6a0f	2026-02-06	Warnings	Exact identifier application number: M012
Severe Allergy And Sinus Headache Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	b3c744b8-aa93-505d-f8cf-07995da4283d	2026-02-06	Warnings	Exact identifier application number: M012
NightTime Cold and Flu Multi Symptom	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE	WinCo Foods, LLC	911e6a51-c0f0-491a-b70c-00011ed5e35b	2026-02-06	Warnings	Exact identifier application number: M012
Severe Sinus Daytime, Non-Drowsy	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cc0dc951-5024-4517-9d38-a01699407e7e	2026-02-06	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Pharmacy Value Alliance, LLC	d836c3e2-3b69-41f3-b166-21270550e8ab	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Publix Super Markets, Inc.	81b1d5bb-f813-4f79-9559-2494db33ad3c	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	6499f854-2995-48cb-9c80-be6524b3db43	2026-02-05	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	52a398eb-e593-458b-9c42-6f653ca391be	2026-02-04	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Hy-Vee, Inc.	446de381-6685-748d-e063-6394a90a1b73	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	85aadc86-d979-41a1-849a-e2ccc9014429	2026-02-04	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	fa8c154c-56c6-47de-8e43-9e012b4be95f	2026-02-04	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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	fc670515-a820-4ea7-8786-8ae710798b31	5
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	fc670515-a820-4ea7-8786-8ae710798b31	5
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	fc670515-a820-4ea7-8786-8ae710798b31	5
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	fc670515-a820-4ea7-8786-8ae710798b31	5
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	fc670515-a820-4ea7-8786-8ae710798b31	5
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	fc670515-a820-4ea7-8786-8ae710798b31	5
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	fc670515-a820-4ea7-8786-8ae710798b31	5
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	fc670515-a820-4ea7-8786-8ae710798b31	5
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	fc670515-a820-4ea7-8786-8ae710798b31	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9012-48	00363901248	1 KIT in 1 PACKAGE, COMBINATION (0363-9012-48) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 kit	2021-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens Non-Drowsy Daytime & Nighttime Cold and Flu	Walgreens	2026-01-19	HUMAN OTC DRUG LABEL	5