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 25 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. edcb8451-6fa7-4bc2-95f6-2a0806f7f3da 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 576660ed-203a-4842-9d39-c5be10daf976 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 1796b3ec-833a-4cf1-ba50-bc4da827f84f 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. d923fa75-f556-45e3-9f52-39a62e89984b 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. cd3ede8c-2c77-4d81-8dff-8198025a2156 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f5f9b-4192-15e6-e053-2995a90a6457 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC 2b494372-de59-e462-e063-6294a90a08da 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City a225d515-430d-4e34-846c-0bfec3e74109 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 372f99c9-4ad3-4631-b8c8-2a34c47343cc 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 Warnings Exact identifier application number: M022
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