Home NDC 72854-261 MUCINEX INSTASOOTHE
Product NDC 72854-261
11-digit product format 728540261
Labeler code 72854
Product ID 72854-261_5a5de58d-7914-1b01-e063-6394a90a4f95
Type HUMAN OTC DRUG
Nonproprietary name HEXYLRESORCINOL
Dosage form LOZENGE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-01
Substance HEXYLRESORCINOL
Active strength 2.4 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…
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 SOOTHING COMFORT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEXYLRESORCINOL 2.4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9QTB5E82N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 247463 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 72854-261-14 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 140 in 1 BAG LOZENGE 140 5 72854-261-14 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 1 in 1 POUCH LOZENGE 1 5 72854-261-20 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 20 in 1 BAG LOZENGE 20 5 72854-261-20 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 1 in 1 POUCH LOZENGE 1 5 72854-261-40 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 40 in 1 BAG LOZENGE 40 5 72854-261-40 MUCINEX INSTASOOTHESORE THROAT PLUS SOOTHING COMFORT 1 in 1 POUCH LOZENGE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-261 MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT (HEXYLRESORCINOL) LOZENGE [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 6 package rows 20250410_91cd2964-5d83-4e40-bc18-e3e5462f454a.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 72854-261-14 72854026114 140 in 1 BAG Historical 72854-261-20 72854026120 20 POUCH in 1 BAG (72854-261-20) / 1 LOZENGE in 1 POUCH 20 pouch 2021-07-01 0000-00-00 No No Current 72854-261-40 72854026140 40 POUCH in 1 BAG (72854-261-40) / 1 LOZENGE in 1 POUCH 40 pouch 2021-07-01 0000-00-00 No No Current