Sunmark Chest Congestion Relief PE

Product NDC: 49348-774
11-digit product format: 493480774
Labeler code: 49348
Product ID: 49348-774_06fe6676-29a9-4deb-aa91-b28365e68afb
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin/phenylephrine
Dosage form: TABLET
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-06-05
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 400; 10 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Sunmark Chest Congestion Relief PE
Brand name suffix: PE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1304111	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
f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-774-09	Sunmark Chest Congestion Relief PEPE	1 in 1 CARTON	TABLET	1		4
49348-774-09	Sunmark Chest Congestion Relief PEPE	50 in 1 BOTTLE	TABLET	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-774-09	EA - Each	49348-774	eac4436c-69b7-407d-9dff-5cfe4755e476	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-774	SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [STRATEGIC SOURCING SERVICES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241220_f94ae469-4c79-4ce9-9a3d-3bdc645be6d9.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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime Soft Chews	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2024-09-05	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	344282fc-3bd1-4f49-9bd1-08c5a58d1f73	2024-09-05	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Exact identifier application number: M012
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Exact identifier application number: M012
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Exact identifier application number: M012
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Exact identifier application number: M012
nasal mist	OXYMETAZOLINE HCL	CVS Pharmacy	b71c557a-eb93-40d1-87c4-847f5468fc1e	2024-08-28	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Kroger Company	0a24d98a-5950-49de-8b77-ea880b08d2c5	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HCL	Topco Associates LLC	b5434599-5485-4949-9d76-b1ef3ad17c1a	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f1dd78e0-f700-4469-85d6-18cc299e8746	2024-08-28	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HCL	United Natural Foods, Inc. dba UNFI	69308693-a094-42a9-a041-e73647a25cc1	2024-08-27	Warnings	Exact identifier application number: M012
signature care nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f9ac80d1-3753-412b-a407-18a6b50e5d1c	2024-08-27	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	20ac6010-84f4-eeff-e063-6294a90a50a7	2024-08-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
1304111	guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	4
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-774-09	49348077409	1 BOTTLE in 1 CARTON (49348-774-09) / 50 TABLET in 1 BOTTLE	1 bottle	2019-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Strategic Sourcing Services LLC \| Reese Pharmaceutical Co	2024-12-18	HUMAN OTC DRUG LABEL	4