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 118 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS	WALGREENS	2be0a699-e6ad-ef56-e063-6394a90aaca5	2025-04-03	Warnings	Exact identifier application number: M012
Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	44fb27d3-5125-4511-84d2-76555bc46e66	2025-04-03	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	31b8ad0a-3637-03db-e063-6394a90acdc3	2025-04-01	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	31aa54d8-df8d-f1ae-e063-6294a90a9622	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Exact identifier application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	Warnings	Exact identifier application number: M012
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	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