Home NDC 72854-265 MUCINEX INSTASOOTHE
Product NDC 72854-265
11-digit product format 728540265
Labeler code 72854
Product ID 72854-265_52d8efe8-112c-ea31-e063-6394a90aa2c1
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE and Menthol, Unspecified Form
Dosage form SPRAY
Route ORAL
Labeler Reckitt Benckiser LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-01
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 7; 1 g/100mL; g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 MUCINEX INSTASOOTHE
Brand name suffix SORE THROAT PLUS PAIN RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 7 g/100mL MENTHOL, UNSPECIFIED FORM 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2560240 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72854-265-04 MUCINEX INSTASOOTHESORE THROAT PLUS PAIN RELIEF 115 mL in 1 BOTTLE, SPRAY SPRAY 115 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-265 MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) SPRAY [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240202_6140d487-d87c-4954-9247-83492bcc5738.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 27 of 40 · 786 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 72854-265-04 72854026504 115 mL in 1 BOTTLE, SPRAY (72854-265-04) 115 ml 2021-07-01 0000-00-00 No No Current