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 170 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier application number: M012
RESFRIOL D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	0e9c96b9-41ac-0faf-e063-6294a90a8ab5	2024-01-26	Warnings	Exact identifier application number: M012
Allergy Relief	ALLERGY RELIEF	Good Sense	bb709377-7bb3-4931-a2b6-2443aee07c12	2024-01-26	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	2024-01-23	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Honey Lemon	MENTHOL	Cardinal Health 110, Inc.	fe90dc33-2815-8296-e053-6294a90ac1df	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Cardinal Health 110, Inc.	fe91543e-a798-6399-e053-6394a90af5e5	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Black Cherry	MENTHOL	Cardinal Health 110, Inc.	fe90cf63-d286-fa5e-e053-6394a90a7759	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol Honey Lemon	COUGH DROPS MENTHOL	Cardinal Health 110, Inc.	fe5b3f6d-2a2d-f322-e053-6394a90aba04	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol	MENTHOL COUGH DROPS	Cardinal Health 110, Inc.	fe5b557e-a689-a32c-e053-6294a90aadbd	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Cherry	CHERRY FLAVOR COUGH DROPS	Cardinal Health 110, Inc.	fe5b5e57-1368-c62b-e053-6294a90ae82c	2024-01-19	Warnings	Exact identifier application number: M012
Leader Zinc Oxide	ZINC OXIDE	Cardinal Health 110,Inc.	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	2024-01-18	Warnings	Exact identifier application number: M012
Cough and Congestion DM Sugar Free	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	4656e60e-4733-45c1-bf55-d156e45085c6	2024-01-17	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Rugby Laboratories	775f97c0-6f82-49a8-82ac-f1a73920c3ec	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin Plus NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals, Inc.	99afe6a6-1350-49c6-9347-b7e531e35925	2024-01-11	Warnings	Exact identifier application number: M012
Childrens Tukol Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	85fe6f0f-41c8-44d3-a34a-355938da5f72	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	ad437177-08eb-4811-883f-ac543d5bc58c	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Exact identifier application number: M012
HISTEX	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	cc466d33-cf3e-4f1c-a794-6d3d79903adf	2024-01-08	Warnings	Exact identifier application number: M012
HISTEX-DM	DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	836d062c-29f0-4fd7-b65c-771a3bbd52c4	2024-01-08	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