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 156 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exchange Select Nasal	OXYMETAZOLINE HCL	Army & Air Force Exchange Service	40d2090d-c332-4dcb-9f43-5ee467e7b3d1	2024-08-27	Warnings	Exact identifier application number: M012
Signature Care Nasal Decongestant	OXYMETAZOLINE HCL	Safeway	23f0a5b3-59ae-4eb3-9b7d-e6a492060337	2024-08-27	Warnings	Exact identifier application number: M012
DG Health Nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	debcda99-c605-4941-b873-9e4dbae27483	2024-08-27	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Nasal	OXYMETAZOLINE HCL	Amerisource Bergen	d374d697-2b57-4558-a20b-d3d89aea82d7	2024-08-27	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Meijer Distribution Inc	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	2024-08-27	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	e6e51821-03ae-4ec3-82a9-b4a8feacd996	2024-08-27	Warnings	Exact identifier application number: M012
Pyrilamine Maleate and Dextromethorphan Hydrobromide	PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Westminster Pharmaceuticals, LLC	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2024-08-26	Warnings	Exact identifier application number: M012
basic care nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	a154e500-2b45-4242-a26c-9530849f99df	2024-08-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0c0cf76f-2dd3-45ef-e063-6394a90a9fef	2024-08-22	Warnings	Exact identifier application number: M012
Day Cold and Flu and Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	TARGET CORPORATION	08ee56d1-b11d-3e36-e063-6294a90acd5f	2024-08-22	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE	TARGET CORPORATION	0fc523ce-55a7-6384-e063-6394a90aad3f	2024-08-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreens	8045aef9-22bc-4146-b494-dbb1ffef06df	2024-08-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5a2053d4-9c0d-4613-9cf5-0067173f3730	2024-08-16	Warnings	Exact identifier application number: M012
QUALITY CHOICE Long Acting Cough Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Marketing Association, Inc.	f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c	2024-08-16	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	458594e1-8d99-4de3-8923-2fd8ce2fc406	2024-08-16	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	54e0d57e-1f48-45e2-86b3-0e50775996f4	2024-08-15	Warnings	Exact identifier application number: M012
SanaTos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	1fc1408c-c540-39ab-e063-6394a90aa477	2024-08-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	489645ad-d7da-5f52-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6c949602-e0c8-40ce-8fb3-5147f406fa04	2024-08-14	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	3dbdf020-ca17-1197-e054-00144ff8d46c	2024-08-13	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