Home NDC 49035-165 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.
DailyMed Product Concepts# 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 Uploaded 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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# 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