Mucinex
- Product NDC
- 72854-223
- Requested package NDC
- 72854-223-20
- 11-digit product format
- 728540223
- Labeler code
- 72854
- Product ID
- 72854-223_51a2ac68-9003-93ef-e063-6294a90abd6b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium, Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- ANDA076518
- Marketing category
- ANDA
- Marketing start
- 2026-07-01
- Substance
- NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 220; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG BASE;120MG | TABLET, EXTENDED RELEASE / ORAL | 2004-03-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076518-001 | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | 220MG;120MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2004-03-17 | f41ea6bd6efb… |
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
- Brand name suffix
- DS 12HR COLD, FEVER and SINUS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN SODIUM | 220 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9TN87S3A3C | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1367426 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4e7e6674-c1ce-ea61-e063-6294a90afe04 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Mucinex DS 12HR COLD, FEVER and SINUS | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4e7e6674-c1ce-ea61-e063-6294a90afe04 | 2026-05-12 | Warnings | 076518 ANDA076518 72854-223-20 72854-223 72854022320 |
| Aleve-D Sinus and Headache | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5ab980c0-c48a-233b-e053-2991aa0a4fd1 | 2025-12-04 | Warnings | 076518 ANDA076518 |
| Aleve-D Sinus and Cold | NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 599ea6c8-03ad-536e-e053-2991aa0a83a3 | 2025-12-04 | Warnings | 076518 ANDA076518 |
| Leader All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 83f7cfbb-ab84-4594-ae7a-4a657385c8a7 | 2025-04-25 | Warnings | 076518 ANDA076518 |
| All Day Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Walgreen Company | b0417ce5-3a5e-42cb-8672-9f2b133c91ca | 2025-04-25 | Warnings | 076518 ANDA076518 |
| Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | cb78330b-d8a3-4c16-bbb0-d31368a542e6 | 2025-04-18 | Warnings | 076518 ANDA076518 |
| Topcare Sinus and Cold D | NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL | Topco Associates LLC | 55c177ce-1729-4a9b-a5ae-2b6c96fbc27a | 2025-04-17 | Warnings | 076518 ANDA076518 |
| Sudafed Sinus 12 Hour Pressure plus Pain | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 305adca3-cdae-41e5-a10a-99d9dd0fe390 | 2024-11-08 | Warnings | 076518 ANDA076518 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72854-223-20 | 72854022320 | 2 BLISTER PACK in 1 CARTON (72854-223-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2026-07-01 | No | No | Current |