NIGHTTIME COLD AND FLU

Product NDC: 41226-694
11-digit product format: 412260694
Labeler code: 41226
Product ID: 41226-694_2dc8828e-abd9-8993-e063-6294a90afc8c
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Kroger Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-05-11
Substance: DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE
Active strength: 15; 325; 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: 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	41226-694-24	`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	41226-694-24	`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	41226-694-24	`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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
ACETAMINOPHEN	325 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
9D2RTI9KYH	Internal UNII lookup
362O9ITL9D	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
bc0115a3-5322-855d-e053-2995a90aba27	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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41226-694-24	2025-02-10	C162847	48780-1	2cef2736-652c-d83d-e063-dadaa90ab31f	694T KROGER 41226 694 Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate CT 24
41226-694-24	2025-01-30	C162847	48780-1	2cef2736-652c-d83d-e063-dadaa90ab31f	694T KROGER 41226 694 Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate CT 24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41226-694-24	NIGHTTIME COLD AND FLU	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		4
41226-694-24	NIGHTTIME COLD AND FLU	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41226-694	NIGHTTIME COLD AND FLU (DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [KROGER COMPANY]	4	Current NDC, Legacy NDC, 2 package rows	20250212_bc0115a3-5322-855d-e053-2995a90aba27.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 47 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 daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	51e34704-5e6b-4e80-836c-ddbc24a451b2	2026-03-06	Warnings	Exact identifier application number: M012
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Sportpharm LLC	7f4e8d37-8c6b-4849-b86c-4335a0bcac1c	2026-03-06	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu Kit	DAYTIME AND NIGHTTIME COLD AND FLU KIT	Allegiant Health	0533db78-7809-46ea-9998-deb5f6f1d0d9	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Better Living Brands, LLC	0153294d-7f52-4d92-8db8-daeca3e29a3b	2026-03-06	Warnings	Exact identifier application number: M012
Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution, Inc.	87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e	2026-03-06	Warnings	Exact identifier application number: M012
RYNEX PE	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	EDWARDS PHARMACEUTICALS, INC.	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	2026-03-05	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	042f9449-4af0-4b15-bb3e-236afeb1e11f	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Amerisource Bergen	087a3a0b-8d3f-45ed-8807-0af47b446cac	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	NUVICARE LLC	6c4bc7d1-09d9-4311-8457-a1d47ab02a5a	2026-03-05	Warnings	Exact identifier application number: M012
Allergy Relief childrens	DIPHENHYDRAMINE HCL	WALMART INC.	dceb99a9-4aa3-4acc-b632-9a4ba8c87919	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMAZON.COM SERVICES LLC	26101105-a6cf-4b51-a639-9d078542fea3	2026-03-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	3a976e90-c6af-4414-984e-9987158c9e98	2026-03-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	714e93ec-0aa9-4be2-9311-399e82f148e0	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	d1131759-dd2e-4c06-bb73-92dd975f5511	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AMAZON.COM SERVICES LLC	6bbe8cc9-7a60-4476-b5cf-b13c5bebff26	2026-03-04	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5a1dfaf3-370d-4ac7-a72d-a48863a35741	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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	bc0115a3-5322-855d-e053-2995a90aba27	4
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	bc0115a3-5322-855d-e053-2995a90aba27	4
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	bc0115a3-5322-855d-e053-2995a90aba27	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-694-24	41226069424	2 BLISTER PACK in 1 CARTON (41226-694-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIGHTTIME COLD AND FLU	Kroger Company \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-02-10	HUMAN OTC DRUG LABEL	4