Home NDC 67091-212 Cold and Head Congestion Relief
Product NDC 67091-212
11-digit product format 670910212
Labeler code 67091
Product ID 67091-212_2d9c9b1f-1049-497e-9d6e-ab7e8777bf46
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler WinCo Foods, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-08-06
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 Cold and Head Congestion Relief
Brand name suffix Severe
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 67091-212-24 Cold and Head Congestion ReliefSevere 12 in 1 BLISTER PACK TABLET, FILM COATED 12 14 67091-212-24 Cold and Head Congestion ReliefSevere 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 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-212 COLD AND HEAD CONGESTION RELIEF SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20240323_a39778ba-1f63-4495-8e9b-44b0bdd7f71a.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 73 of 178 · 3,551 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 67091-212-24 67091021224 2 BLISTER PACK in 1 CARTON (67091-212-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-06 0000-00-00 No No Current