Cold Flu and Sore Throat

Product NDC: 56062-197
11-digit product format: 560620197
Labeler code: 56062
Product ID: 56062-197_253dbd0a-a1e8-72d7-e063-6394a90a8069
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: PUBLIX SUPER MARKETS INC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-09-13
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 200; 5 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	56062-197	56062-197-02	D	Discontinued by firm		2026-10-23

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Flu and Sore Throat
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1110988	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
68a5930b-37db-439d-8fb9-7d7de07d8465	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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
56062-197-02	Cold Flu and Sore Throat	2 in 1 CARTON	TABLET, COATED	2	5
56062-197-02	Cold Flu and Sore Throat	10 in 1 BLISTER PACK	TABLET, COATED	10	5
56062-197-04	Cold Flu and Sore Throat	10 in 1 BLISTER PACK	TABLET, COATED	10	5
56062-197-04	Cold Flu and Sore Throat	2 in 1 CARTON	TABLET, COATED	2	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-197	COLD FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [PUBLIX SUPER MARKETS INC]	5	Current NDC, Legacy NDC, 4 package rows	20241027_68a5930b-37db-439d-8fb9-7d7de07d8465.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 123 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	df31056b-d0eb-4094-98d9-3d444210d50d	2025-01-16	Warnings	Exact identifier application number: M012
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Reliable 1 Laboratories LLC	28dd9baa-43bd-b60a-e063-6394a90a8cf7	2025-01-15	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Reliable 1 Laboratories LLC	ae469d4f-91c4-cff0-e053-2995a90a0497	2025-01-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL 25 mg	DIPHENHYDRAMINE HCL	Reliable 1 Laboratories LLC	32f58cb3-941f-263b-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCl 25 mg	DIPHENHYDRAMINE HCL	Reliable 1 Laboratories LLC	32fa40ad-fed5-586f-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy, Inc	2741ba44-1cc7-1812-e063-6394a90a8faa	2025-01-14	Warnings	Exact identifier application number: M012
DAY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	2b941963-8a8c-4148-e063-6294a90a1dfb	2025-01-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	SDA Laboratories, Inc.	437e6a13-a4ff-4f98-8973-042f224ee85e	2025-01-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	SDA Laboratories, Inc.	6a520986-1004-4ee6-9a47-1dfd90bb1b2c	2025-01-13	Warnings	Exact identifier application number: M012
good sense daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	5ddf3283-94e4-465d-842a-471ee946c330	2025-01-10	Warnings	Exact identifier application number: M012
Vicks VapoSteam	CAMPHOR (SYNTHETIC)	Kaz USA, Inc	c28da455-07ad-4053-8b9e-fc559f9a3f72	2025-01-10	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	45ac210a-8c54-4469-8e10-e6fe52b89cb5	2025-01-09	Warnings	Exact identifier application number: M012
Meclizine HCL	MECLIZINE HCL 25MG CHEWABLE TABLETS	Aphena Pharma Solutions - Tennessee, LLC	02d1af4d-d97d-4019-a5bf-3ec391238676	2025-01-09	Warnings	Exact identifier application number: M012
HISTEX PD Drops New Formulation	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	0c693f15-5d76-3dbf-e063-6294a90af9ac	2025-01-08	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HBR 15 MG	DEXTROMETHORPHAN HBR 15 MG	AMZ789 LLC	e2175017-6a0d-0155-e053-2995a90a65d6	2025-01-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Health Pharma USA LLC	29bb7822-76c6-e39d-e063-6294a90a64fb	2025-01-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	CHILDRENS ALLERGY RELIEF	Allegiant Health	cb6df361-b8e5-4e2f-945f-c20159d76c4f	2025-01-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	WinCo Foods, LLC	bb7a9fed-dc04-4c31-aa7f-4185d955242c	2025-01-06	Warnings	Exact identifier application number: M012
Leader Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	207b2677-aaad-4fe4-a96d-963b7dcfba70	2025-01-06	Warnings	Exact identifier application number: M012
Allergy Relief Caplet	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	126c05e7-2cd9-47d3-96c3-82305714e1db	2025-01-02	Warnings	Exact identifier application number: M012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1110988	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	68a5930b-37db-439d-8fb9-7d7de07d8465	5
1110988	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	68a5930b-37db-439d-8fb9-7d7de07d8465	5
1110988	APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	68a5930b-37db-439d-8fb9-7d7de07d8465	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56062-197-02	56062019702	2 BLISTER PACK in 1 CARTON (56062-197-02) > 10 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2019-09-13	0000-00-00	No	No	Current
56062-197-04	56062019704	2 BLISTER PACK in 1 CARTON (56062-197-04) / 10 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2021-03-01	0000-00-00	No	No	Current