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 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	DISCOUNT DRUG MART	06673358-1afc-4d75-e063-6394a90a6ab1	2025-09-03	Warnings	Exact identifier application number: M012
ValuMeds Cough Relief, Dextromethorphan Hbr	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	b16a81db-d9bc-4cce-8ec2-dc189184931e	2025-09-03	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	256d96f0-67bf-42d2-85ef-f49625c5910f	2025-09-02	Warnings	Exact identifier application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	2256623c-7642-4c39-b022-bfaecc861f1c	2025-09-02	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ef574f18-e28d-46bb-87fd-2f3b4df6dc68	2025-09-02	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger Company	f4429475-47f9-451a-bfcc-24b5ef333923	2025-09-02	Warnings	Exact identifier application number: M012
dg health night time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1	2025-08-29	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Medical Group Care LLC	3d70ba70-eb11-f148-e063-6294a90a4c7c	2025-08-28	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Army & Air Force Exchange Service	3d7109a5-4fe1-039b-e063-6394a90a1392	2025-08-28	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3d710deb-e42d-13eb-e063-6394a90a56e1	2025-08-28	Warnings	Exact identifier application number: M012
Sinus Relief Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger Company	98de5cff-3ff5-49b0-bef9-5b9ebb86491e	2025-08-27	Warnings	Exact identifier application number: M012
Nighttime SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	H E B	0a178114-0748-4a92-9b60-a7a0a8b72287	2025-08-26	Warnings	Exact identifier application number: M012
Adult Bisolvine Adult	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	8cde5e39-a338-45af-b847-3823627f29c5	2025-08-25	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	997eb228-09cb-47ad-acbb-363b05c67635	2025-08-25	Warnings	Exact identifier application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREE	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	644f39d8-7cd6-43dd-9265-546d01d32e8c	2025-08-22	Warnings	Exact identifier application number: M012
SanaTos Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	df260190-89e7-b338-e053-2995a90a32cb	2025-08-22	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	VerityRx	9ca6c0f8-71d1-4953-8e98-3311c4664011	2025-08-22	Warnings	Exact identifier application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum Strength	PHENYLEPHRINE HCL	Salado Sales, Inc.	9056fa58-d6aa-4df5-97e0-9be3f2332f86	2025-08-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	MY IMPORTS USA LLC	3cde0c23-5c5c-9715-e063-6294a90a9462	2025-08-21	Warnings	Exact identifier application number: M012
Severe Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	258d27a9-fea6-4076-8dfa-77c7e982d250	2025-08-20	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