FDA.reportPublic FDA data

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

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
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1243679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-165-09Severe Congestion ReliefMaximum Strength Sinus10 in 1 BLISTER PACKTABLET, FILM COATED1014
49035-165-09Severe Congestion ReliefMaximum Strength Sinus2 in 1 CARTONTABLET, FILM COATED214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1USEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-165SEVERE CONGESTION RELIEF MAXIMUM STRENGTH SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]13Current NDC, Legacy NDC, 2 package rows20241206_59918b8b-5c91-468f-834e-66020dc1ae12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN59918b8b-5c91-468f-834e-66020dc1ae1214
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD59918b8b-5c91-468f-834e-66020dc1ae1214
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY59918b8b-5c91-468f-834e-66020dc1ae1214
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY59918b8b-5c91-468f-834e-66020dc1ae1214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-165-09490350165092 BLISTER PACK in 1 CARTON (49035-165-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2014-06-300000-00-00NoNoCurrent