Severe Congestion Relief

Product NDC: 49035-165
11-digit product format: 490350165
Labeler code: 49035
Product ID: 49035-165_578484ea-2065-4307-992d-c442bbd619d0
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-30
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 200; 5 mg/1; 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: Severe Congestion Relief
Brand name suffix: Maximum Strength Sinus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
GUAIFENESIN	200 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
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
1243679	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
59918b8b-5c91-468f-834e-66020dc1ae12	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49035-165-09	Severe Congestion ReliefMaximum Strength Sinus	10 in 1 BLISTER PACK	TABLET, FILM COATED	10		14
49035-165-09	Severe Congestion ReliefMaximum Strength Sinus	2 in 1 CARTON	TABLET, FILM COATED	2		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-165	SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	13	Current NDC, Legacy NDC, 2 package rows	20241206_59918b8b-5c91-468f-834e-66020dc1ae12.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 129 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum No Mess Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	f4675bc1-01cc-4a33-a3bf-bfc99230fe32	2024-12-17	Warnings	Exact identifier application number: M012
Mentholatum Cherry Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	de01225a-eabb-4972-bf3a-3e5a0e44abef	2024-12-17	Warnings	Exact identifier application number: M012
Rite Aid Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rite Aid Corporation	198a666a-3f34-4e4f-89e8-ec7f412f00af	2024-12-17	Warnings	Exact identifier application number: M012
Equate Childrens Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	372e66a6-1f1f-4aa3-a2ed-d215fafee9b9	2024-12-17	Warnings	Exact identifier application number: M012
Caring Mill Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	FSA Store Inc.	caa83419-c332-4b92-b151-22da2fa85289	2024-12-17	Warnings	Exact identifier application number: M012
Always Save Chest Congestion Relief GUAF	GUAIFENESIN	Valu Merch	9d81d88b-2db9-4891-942b-fecb1be961dd	2024-12-17	Warnings	Exact identifier application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	24a75ffa-c2a7-71a9-e063-6394a90a0e25	2024-12-17	Warnings	Exact identifier application number: M012
Allergy 36ct, Caseys 4good	DIPHENHYDRAMINE HCL 25MG	Lil' Drug Store Products, Inc.	04b78b23-424d-9762-e063-6394a90a52e3	2024-12-16	Warnings	Exact identifier application number: M012
Sinus Relief, Caseys 4good	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store Products, Inc.	033837c0-fa68-a38d-e063-6394a90a9832	2024-12-16	Warnings	Exact identifier application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	cfab9b80-0580-4482-b6e3-0aab875b5797	2024-12-16	Warnings	Exact identifier application number: M012
Allergy Relief, 24-7 Lift by 7-Eleven	DIPHENHYDRAMINE HCL 25MG	Lil' Drug Store products, Inc.	04c9db9a-95ef-3a48-e063-6294a90a4e8e	2024-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe, 24/7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET	Lil' Drug Store Products, Inc.	05cc7185-d49d-82a3-e063-6294a90a568e	2024-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Severe, 24-7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store products, Inc.	05d0410f-164e-e7ee-e063-6394a90a2aaa	2024-12-16	Warnings	Exact identifier application number: M012
tussin dm max daytime nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN	CVS Pharmacy	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	2024-12-16	Warnings	Exact identifier application number: M012
Leader Childrens Multi Symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	169ff9cf-fcf5-46a6-b460-259421f2ec07	2024-12-16	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	59918b8b-5c91-468f-834e-66020dc1ae12	14
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	59918b8b-5c91-468f-834e-66020dc1ae12	14
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	59918b8b-5c91-468f-834e-66020dc1ae12	14
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	59918b8b-5c91-468f-834e-66020dc1ae12	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-165-09	49035016509	2 BLISTER PACK in 1 CARTON (49035-165-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2014-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equate 44-615-SM	Wal-Mart Stores Inc \| LNK International, Inc.	2025-12-12	HUMAN OTC DRUG LABEL	14