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		2026-10-21

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 120 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	131b1f17-cd86-f9b3-e063-6294a90a3028	2025-02-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates, LLC	17d0dbc7-c8c2-7917-e063-6394a90a42af	2025-02-12	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	bc00bbf8-52bb-fa75-e053-2a95a90a9406	2025-02-11	Warnings	Exact identifier application number: M012
Daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS	TIME CAP LABORATORIES, INC.	fd24653e-c4fa-3c09-e053-6394a90aaa9e	2025-02-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS	TIME CAP LABORATORIES INC.	fd81dd4b-9617-f4c1-e053-6394a90a5e72	2025-02-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	DOLGENCORP, LLC	be2207b7-b8f8-7fba-e053-2a95a90abd16	2025-02-10	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Kroger Company	bc0115a3-5322-855d-e053-2995a90aba27	2025-02-10	Warnings	Exact identifier application number: M012
Day time high blood pressure cold and flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Camber Consumer Care	09fbd872-0970-4864-9308-4a7b85983920	2025-02-10	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f05e11ce-c908-acbc-e053-2a95a90a584e	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f035c499-cda6-fadf-e053-2995a90af457	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6d977ce-bbca-f1cc-e053-6394a90acc96	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da36d3-496d-2336-e053-6394a90a0f83	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da2e02-42c7-1ede-e053-6394a90aff5f	2025-02-09	Warnings	Exact identifier application number: M012
MUCOSA DM	GUAIFENESIN DEXTROMETHORPHAN	TIME CAP LABORATORIES, INC.	62c1f4aa-6571-414c-9a58-31e107b7db97	2025-02-08	Warnings	Exact identifier application number: M012
Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	2d95d5a4-34dc-e195-e063-6394a90a39da	2025-02-07	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	5d56ccd2-1c28-4750-9454-44809091ad2f	2025-02-05	Warnings	Exact identifier application number: M012
SanaTos Mucus Relief Cold Toddlers	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	60672feb-1421-651e-e053-2a91aa0af41d	2025-02-04	Warnings	Exact identifier application number: M012
SofSkin Vaporizing Chest Rub and Cough Suppressant	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Viny Health and Beauty Inc	34626cf5-64fc-15c0-e063-6294a90aa310	2025-02-04	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	17922df7-7867-4300-bd99-55aee7b60606	2025-02-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	f4b8ff54-47b5-4d18-bf4e-b101abb22a24	2025-02-03	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