MAXIMUM STRENGTH COLD AND FLU

Product NDC: 55319-628
11-digit product format: 553190628
Labeler code: 55319
Product ID: 55319-628_2e2c825a-b5bd-9b82-e063-6394a90aa88f
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: FAMILY DOLLAR SERVICES
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-08-24
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Active strength: 10; 5; 325; 200 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 · 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	55319-628-16	`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	55319-628-16	`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	55319-628-16	`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: MAXIMUM STRENGTH COLD AND FLU
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
495W7451VQ	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
a7343bea-53cc-4621-e053-2a95a90a2a5f	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
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
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-628-16	2025-02-15	C162847	48780-1	2cef2736-a965-d83d-e063-dadaa90ab31f	628T FAMILY DOLLAR - 628T MAXIMUM STRENGTH COLD AND FLU 55319-628
55319-628-16	2025-01-30	C162847	48780-1	2cef2736-a965-d83d-e063-dadaa90ab31f	628T FAMILY DOLLAR - 628T MAXIMUM STRENGTH COLD AND FLU 55319-628

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-628-16	MAXIMUM STRENGTH COLD AND FLU	16 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	16		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-628	MAXIMUM STRENGTH COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR SERVICES]	4	Current NDC, Legacy NDC, 1 package rows	20250217_a7343bea-53cc-4621-e053-2a95a90a2a5f.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 175 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	Riclan S.A.	f6271e85-9ca2-41d3-9bff-a13670ac5b80	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Strawberry	MENTHOL	Riclan S.A.	da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457	2023-10-26	Warnings	Exact identifier application number: M012
DG Health Cough Drops Assorted Flavors	MENTHOL	Dollar General Corporation	c731d255-40f2-3cb3-e053-2a95a90a8877	2023-10-26	Warnings	Exact identifier application number: M012
ALKA SELTZER PLUS Cold Day and Night Effervescent	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Sincronia Logistica, S.A. de C.V.	c478df69-823a-4112-8f44-323249a9f38f	2023-10-23	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	169006cb-7dc2-4113-a289-0b1f14e784b7	2023-10-23	Warnings	Exact identifier application number: M012
Night-Time Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	HealthLife of USA	2ffd62a6-703f-4cb0-bb13-49719c004d00	2023-10-21	Warnings	Exact identifier application number: M012
Day-Time Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN	HealthLife of USA	c5f6cf22-2aaa-40e1-b7b3-448e55898d62	2023-10-21	Warnings	Exact identifier application number: M012
PENTREXCILINA	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Healthlife of USA	ae9ada14-0ec8-4c01-a874-237f2108936a	2023-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	APNAR PHARMA LP	e5004c10-3877-c199-e053-2a95a90aa8ac	2023-10-21	Boxed warning, Warnings	Exact identifier application number: M012
Day and Night Multi Symptom Cold and Flu Relief	DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF	Intrivo Diagnostics Inc.	a311bf39-de6c-4ed5-949e-718ad8be1e49	2023-10-13	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0d65c4a9-938c-4a89-b1f1-d9ada8a8c587	2023-10-10	Warnings	Exact identifier application number: M012
Triacting Daytime Cold Cough Childrens	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8656aa2e-9546-4de4-9ecc-ce99bf903333	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	a33ae35b-1cde-4a3d-a836-3b169e4f1bb9	2023-10-10	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	553d01a9-e8ad-4797-b55b-32f134f08af9	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	8781e2c5-ad46-4615-a0d9-879590e86f95	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	419df833-1f33-45cf-bab3-730c928d5887	2023-10-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	93a5cb36-3262-4224-a5be-5ea1619a67bd	2023-10-10	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	CVS Pharmacy	782fb103-cd9f-4e8c-8f3a-1fb131b9eda6	2023-10-09	Warnings	Exact identifier application number: M012
Cold and Congestion Childrens Nighttime	DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL	Walgreens	a7847413-e556-4f88-8a7f-a8528afbe927	2023-10-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	06d2c6cf-0adb-91b9-e063-6294a90aff52	2023-10-03	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

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	a7343bea-53cc-4621-e053-2a95a90a2a5f	4
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	a7343bea-53cc-4621-e053-2a95a90a2a5f	4
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	a7343bea-53cc-4621-e053-2a95a90a2a5f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-628-16	55319062816	16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16)	2020-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
628T FAMILY DOLLAR - 628T MAXIMUM STRENGTH COLD AND FLU 55319-628	FAMILY DOLLAR SERVICES \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LTD	2025-02-15	HUMAN OTC DRUG LABEL	4