DAYTIME SEVERE COLD AND FLU

Product NDC: 41226-625
11-digit product format: 412260625
Labeler code: 41226
Product ID: 41226-625_2e141369-9e32-7624-e063-6294a90a25f9
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: KROGER COMPANY
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-29
Substance: PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 5; 200; 325; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 · 9 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	41226-625-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41226-625-16	`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	41226-625-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41226-625-16	`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	41226-625-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41226-625-16	`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: DAYTIME SEVERE COLD AND FLU
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1
GUAIFENESIN	200 mg/1
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
495W7451VQ	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1656815	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
9bb7aaf0-6698-9a5c-e053-2a95a90a097c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
41226-625-16	2025-02-14	625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU
41226-625-24	2025-02-14	625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU
41226-625-16	2025-01-30	625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU
41226-625-24	2025-01-30	625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41226-625-24	DAYTIME SEVERE COLD AND FLU	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		4
41226-625-24	DAYTIME SEVERE 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
41226-625	DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN) CAPSULE, LIQUID FILLED [KROGER COMPANY]	4	Current NDC, Legacy NDC, 2 package rows	20250216_9bb7aaf0-6698-9a5c-e053-2a95a90a097c.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 152 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Black Cherry Cough Drops	MENTHOL	Boston Nutraceutical Production SL	856f2e1a-2593-99e6-e053-2991aa0ad039	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Boston Nutraceutical Production SL	857363b6-e025-e074-e053-2a91aa0a4379	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Boston Nutraceutical Production SL	857365ba-895e-4a63-e053-2991aa0a8b9f	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Vapor Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	a7062db1-8201-b400-e053-2a95a90a55e8	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	b8f48a47-6871-f7ed-e053-2995a90a16f3	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	856f0bd8-354b-a002-e053-2a91aa0a8022	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	83c4928a-eea6-e176-e053-2991aa0a6bb1	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herbal Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	c2340f56-9a8e-4eea-e053-2995a90a78fc	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herbal Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	a706ee9c-9ed0-d3f1-e053-2a95a90a26d6	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff0b37b-6c08-b687-e053-2a95a90a11a9	2024-10-07	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	efcf2edd-21a3-45f9-e053-2995a90a3865	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff65505-8846-35c2-e053-2a95a90a6b79	2024-10-07	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	eff0fdfe-695a-4e62-e053-2a95a90ab50f	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff1a70f-fa71-52b2-e053-2995a90a038c	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Menthol Cough Drops	HONEY LEMON MENTHOL	Topco Associates LLC	f5be283b-524d-26af-e053-2995a90a3972	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff16ba3-7e30-aa93-e053-2995a90a64cb	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Rompe Pecho SF Flu SF Flu	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06eac696-e8f6-ac50-e063-6394a90a2ed6	2024-10-07	Warnings	Exact identifier application number: M012
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Exact identifier application number: M012
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	4
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	4
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	4
1297288	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	a2508699-08c0-4a22-e053-2a95a90a8a6d	3
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	a2508699-08c0-4a22-e053-2a95a90a8a6d	3
1297288	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	a2508699-08c0-4a22-e053-2a95a90a8a6d	3
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	a2508699-08c0-4a22-e053-2a95a90a8a6d	3
1297288	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	a2508699-08c0-4a22-e053-2a95a90a8a6d	3
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	a2508699-08c0-4a22-e053-2a95a90a8a6d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41226-625-16	41226062516	16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-625-16)		2020-05-29	0000-00-00	No	No	Current
41226-625-24	41226062524	2 BLISTER PACK in 1 CARTON (41226-625-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2020-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU	KROGER COMPANY \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LTD	2025-02-14	HUMAN OTC DRUG LABEL	4
627T KROGER DAY-NIGHT SEVERE COLD AND FLU	KROGER \| TIME CAP LABS INC \| MARKSANS PHARMA LTD	2022-11-02	HUMAN OTC DRUG LABEL	3