Home NDC 37000-951 Vicks Sinex Severe
Product NDC 37000-951
11-digit product format 370000951
Labeler code 37000
Product ID 37000-951_5ce1124b-130f-d11f-e063-6394a90ab947
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl, Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-10
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Active strength 5; 325; 200 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 2027-12-31
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 Vicks Sinex Severe
Brand name suffix All in One Sinus Mucus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37000-951-24 Vicks Sinex SevereAll in One Sinus Mucus 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 11 37000-951-24 Vicks Sinex SevereAll in One Sinus Mucus 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37000-951 VICKS SINEX SEVERE ALL IN ONE SINUS MUCUS (ACETAMINOPHEN, PHENYLEPHRINE HCL, GUAIFENESIN) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 9 Current NDC, Legacy NDC, 2 package rows 20241012_9a106291-edda-2135-e053-2995a90a44fd.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 37000-951-24 37000095124 2 BLISTER PACK in 1 CARTON (37000-951-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2018-07-10 0000-00-00 No No Current