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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 72854-261 | 72854-261-14 | D | Discontinued by firm | 2026-10-16 |
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.
| 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 |
|---|---|
| HEXYLRESORCINOL | 2.4 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R9QTB5E82N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 247463 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 91cd2964-5d83-4e40-bc18-e3e5462f454a | Available on FDA.report |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72854-261-20 | EA - Each | 72854-261 | 088a8fa7-d2ce-4ff3-a40b-39039f286937 | 1 | 2021-09-07 |
| 72854-261-40 | EA - Each | 72854-261 | 72fcdb4f-c4ab-4b76-a237-3670d666d39b | 1 | 2021-09-07 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | af430cf4-f1b4-4b57-b8e3-87df96d655d3 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 2b089fec-cae3-4dc9-964d-d37f732a2f9f | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 6c137a93-4a34-4849-997f-bd0c572466ef | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | e8aa9709-e8f6-47a6-ab29-1fef2309786b | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 8c55b39c-8231-46a1-92ef-9fb4e3f40c1e | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9e82dc54-aeca-457f-b4b9-2f18cc269538 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 1a8f5964-770a-4d14-a7b6-18b5da9159b0 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722cdf3-7671-eb27-e053-2a95a90a09c4 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d722bf24-ae85-54f6-e053-2995a90a1d35 | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721864d-0950-8379-e053-2a95a90a3bcb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | b0e5dc67-da7a-42ac-8657-e8e4da6914be | 2025-01-16 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d721ff57-0111-4bbb-e053-2995a90a1a70 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 8129e871-5f31-4138-ae47-f8978fa6287f | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 0301c1bc-db48-4635-97f5-9eaef7ab9579 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | c0c88180-ccdc-4c48-b262-3ec20d4775d4 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | ba011795-6822-4fff-b9c8-5c91cf9972a7 | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb | 2025-01-16 | Warnings | M022 |
| Defend | BENZOCAINE | Mydent International | 462a5f09-131f-4dfa-a502-547c44e4a4a5 | 2025-01-16 | Warnings | M022 |
| Benzocaine | TOPICAL ANESTHETIC | Everpharm LLC | 2bc57111-0f15-b237-e063-6294a90a4471 | 2025-01-15 | Warnings | M022 |
| Kanka Triple Action | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | 078fcdab-38a1-4a9a-bdd3-e17446591ea8 | 2025-01-09 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 247463 | hexylresorcinol 2.4 MG Oral Lozenge | PSN | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 5 |
| 247463 | hexylresorcinol 2.4 MG Oral Lozenge | SCD | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 5 |
Packages#
| 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 |