Chest Congestion Relief

Product NDC: 49348-729
11-digit product format: 493480729
Labeler code: 49348
Product ID: 49348-729_6c8c7db1-ed1b-4499-ab97-296c6e8fac32
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-08-01
Substance: GUAIFENESIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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: Chest Congestion Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359601	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
da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49348-729-09	Chest Congestion Relief	12 in 1 BLISTER PACK	TABLET	12		4
49348-729-09	Chest Congestion Relief	2 in 1 CARTON	TABLET	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-729-09	EA - Each	49348-729	4a0d884e-20ba-4609-b8ff-cd2a43c7ba68	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-729	CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [STRATEGIC SOURCING SERVICES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241220_da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee.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 160 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	Warnings	Exact identifier application number: M012
Family Wellness Effervescent Cold Relief Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Family Dollar Services, Inc.	4e13511b-fbb5-2523-e054-00144ff88e88	2024-07-03	Warnings	Exact identifier application number: M012
Nighttime Cherry Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	TARGET CORPORATION	1c3f6cbf-a00d-45b9-e063-6394a90a797c	2024-07-02	Warnings	Exact identifier application number: M012
Cold Terminator Cold Relief	PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Wildman Business Group	e8538d9c-f9ba-40b1-b60f-f57921f39b64	2024-07-01	Warnings	Exact identifier application number: M012
Nighttime Severe Honey Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1c02e465-8750-a088-e063-6394a90a8efb	2024-06-29	Warnings	Exact identifier application number: M012
ACTIDOM DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	0166322e-7dbb-4658-a5c5-1d0525bb7655	2024-06-28	Warnings	Exact identifier application number: M012
ACTINEL DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ACTIPHARMA, LLC	16660d82-524b-42ca-8581-48237caa13b2	2024-06-28	Warnings	Exact identifier application number: M012
PurgenLabs Acetaminophen	ACTAMINOPHEN	Advanced Rx LLC	915c4608-af1b-4119-8291-4ce9fd701d76	2024-06-28	Warnings	Exact identifier application number: M012
Daytime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	1bc90b2f-612c-e977-e063-6294a90a40b4	2024-06-26	Warnings	Exact identifier application number: M012
Halls Mentholyptus	MENTHOL	Mondelez Global LLC	f5292c5b-5608-4e13-afc2-4f3d7133da88	2024-06-25	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	75638f29-7f2a-46b0-b8a0-e87bc7d6eba1	2024-06-25	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	TARGET CORPORATION	130ca5f1-2951-ec6f-e063-6394a90a754f	2024-06-24	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	TARGET CORPORATION	08fd1513-30ab-15da-e063-6394a90ab57d	2024-06-21	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	0c0caa59-0637-bc33-e063-6294a90ae244	2024-06-21	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	de401eb4-3282-4298-8a51-15d268253464	2024-06-21	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	4
359601	guaifenesin 400 MG Oral Tablet	SCD	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-729-09	49348072909	2 BLISTER PACK in 1 CARTON (49348-729-09) / 12 TABLET in 1 BLISTER PACK	2 blister pack	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 \| Pharbest	2024-12-18	HUMAN OTC DRUG LABEL	4