Home NDC 67091-349 Nasal Decongestant PE and Pain Relief Plus Mucus Relief
Product NDC 67091-349
11-digit product format 670910349
Labeler code 67091
Product ID 67091-349_2860d8a0-4862-9d45-e063-6294a90af22e
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Winco Foods, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-25
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 Nasal Decongestant PE and Pain Relief Plus Mucus Relief
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 Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 495W7451VQ, 04JA59TNSJ Rxcui 1243679
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-349-24 Nasal Decongestant PE and Pain Relief Plus Mucus Relief 2 in 1 CARTON TABLET, COATED 2 4 67091-349-24 Nasal Decongestant PE and Pain Relief Plus Mucus Relief 12 in 1 BLISTER PACK TABLET, COATED 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-349 NASAL DECONGESTANT PE AND PAIN RELIEF PLUS MUCUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [WINCO FOODS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241206_31531f90-8933-46ab-b722-cb63e7738639.zip
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 67091-349-24 67091034924 2 BLISTER PACK in 1 CARTON (67091-349-24) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2017-10-25 0000-00-00 No No Current