Home NDC 49035-053 Cold and Flu
Product NDC 49035-053
11-digit product format 490350053
Labeler code 49035
Product ID 49035-053_40621759-f1e2-4dc6-9f26-726a82e19b40
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wal-Mart Stores Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-08-04
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Cold and Flu
Brand name suffix severe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1110988 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 49035-053-08 Cold and Flusevere 12 in 1 BLISTER PACK TABLET, FILM COATED 12 15 49035-053-08 Cold and Flusevere 2 in 1 CARTON TABLET, FILM COATED 2 15 49035-053-42 Cold and Flusevere 12 in 1 BLISTER PACK TABLET, FILM COATED 12 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-053 COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] 14 Current NDC, Legacy NDC, 3 package rows 20250519_9fca25dc-f63e-487a-8b7c-84d65ea51cb5.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 49035-053-08 49035005308 2 BLISTER PACK in 1 CARTON (49035-053-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-04 0000-00-00 No No Current 49035-053-42 49035005342 12 TABLET, FILM COATED in 1 BLISTER PACK (49035-053-42) 2005-08-04 0000-00-00 No No Current