Application 021620
- Type
- NDA
- Sponsor
- RB HLTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 60MG;1.2GM | Yes | Yes |
| 002 | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 30MG;600MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021620-001 | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | |
| N021620-002 | MUCINEX DM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021620-001 | MUCINEX DM | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2004-04-29 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021620-002 | MUCINEX DM | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2004-04-29 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021620-001 | 6372252 | 2020-04-28 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021620-002 | 6372252 | 2020-04-28 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021620-002 | 7838032 | 2020-04-28 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021620-001 | 6372252 | 2020-04-28 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021620-002 | 6372252 | 2020-04-28 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021620-002 | 7838032 | 2020-04-28 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021620-001 | 6372252 | 2020-04-28 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021620-002 | 6372252 | 2020-04-28 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021620-002 | 7838032 | 2020-04-28 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021620-001 | 6372252 | 2020-04-28 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021620-002 | 6372252 | 2020-04-28 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021620-002 | 7838032 | 2020-04-28 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021620-001 | 6372252 | 2020-04-28 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021620-002 | 6372252 | 2020-04-28 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021620-002 | 7838032 | 2020-04-28 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021620-001 | 6372252 | 2020-04-28 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021620-001 | 6955821 | 2020-04-28 | U-685 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021620-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021620-002 | 6372252 | 2020-04-28 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021620-002 | 6955821 | 2020-04-28 | U-685 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021620-002 | 7838032 | 2020-04-28 | Drug product | ea99ee380514… |
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 DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Select Consumer Group | 3c9c8fb0-8a00-4b0f-e063-6394a90af632 | 2026-08-30 | Warnings | 021620 NDA021620 |
| Mucinex DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 70987d06-d206-445f-bd0d-5e1345b8465c | 2026-06-15 | Warnings | 021620 NDA021620 63824-056 |
| Mucinex DM Maximum Strength | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 588eddc1-fa30-41cc-8ed9-c01319ea21c6 | 2026-05-27 | Warnings | 021620 NDA021620 63824-072 |
| Mucinex DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | c04e67da-51f6-4ce3-9852-419d7b3a3742 | 2026-05-22 | Warnings | 021620 NDA021620 50090-1078 |
| Mucinex DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Sportpharm LLC | 8f4af6dd-6df4-49a7-98cf-655136923734 | 2026-02-26 | Warnings | 021620 NDA021620 |
| MUCINEX DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | fcaf1df9-b396-44f2-94ce-e46e80aba66c | 2025-10-01 | Warnings | 021620 NDA021620 50090-1077 |
| Mucinex DM, TRAVEL BASIX | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | c274b05c-8f05-4980-9a93-77affb322e57 | 2023-10-10 | Warnings | 021620 NDA021620 66715-9724 |
| Mucinex DM Maximum Strength | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | 104b29ed-a377-4436-8e24-413c63579f2e | 2023-07-27 | Warnings | 021620 NDA021620 |
| Mucinex DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Navajo Manufacturing Company Inc. | 4226f394-f85e-45b1-8d5f-7cffb7dd492f | 2023-03-16 | Warnings | 021620 NDA021620 67751-171 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0076 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | walgreens | NDA | Current |
| 11822-7156 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | Rite-Aid | NDA | Current |
| 11822-7156 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | Rite-Aid | NDA | Current |
| 11822-7156 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | Rite-Aid | NDA | Current |
| 17856-0056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | ATLANTIC BIOLOGICALS CORP | NDA | Current |
| 17856-0056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | ATLANTIC BIOLOGICALS CORP | NDA | Current |
| 17856-0056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 29485-6647 | Mucinex | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Mechanical Servants LLC | NDA | Current |
| 29485-6647 | Mucinex | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Mechanical Servants LLC | NDA | Current |
| 29485-6647 | Mucinex | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Mechanical Servants LLC | NDA | Current |
| 29485-6942 | Mucinex | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Mechanical Servants LLC | NDA | Current |
| 30142-706 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | KROGER COMPANY | NDA | Current |
| 30142-706 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | KROGER COMPANY | NDA | Current |
| 30142-706 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | KROGER COMPANY | NDA | Current |
| 30142-991 | Mucus Relief ER DM | Guaifenesin and Dextromethorphan Hydrobromide | KROGER COMPANY | NDA | Current |
| 30142-991 | Mucus Relief ER DM | Guaifenesin and Dextromethorphan Hydrobromide | KROGER COMPANY | NDA | Current |
| 49035-077 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | WALMART STORES, INC. | NDA | Current |
| 49035-077 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | WALMART STORES, INC. | NDA | Current |
| 50090-1077 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-1077 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-1077 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-1078 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-1078 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-2298 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-2298 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 50090-2299 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | A-S Medication Solutions | NDA | Current |
| 51660-054 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | OHM LABORATORIES INC | NDA | Current |
| 51660-073 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | OHM LABORATORIES INC | NDA | Current |
| 52904-650 | Mucinex DM | guaifenesin and dextromethorphan hydrobromide | Select Corporation | NDA | Current |
| 60687-651 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | American Health Packaging | NDA | Current |
| 63824-056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Reckitt Benckiser LLC | NDA | Current |
| 63824-056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-056 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-072 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-072 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-072 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | RB Health (US) LLC | NDA | Current |
| 63824-072 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Reckitt Benckiser LLC | NDA | Current |
| 63868-391 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | CHAIN DRUG MARKETING ASSOCIATION INC | NDA | Current |
| 66715-9724 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9724 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9724 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Lil' Drug Store Products, Inc. | NDA | Current |
| 66715-9724 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Lil' Drug Store Products, Inc. | NDA | Current |
| 67751-171 | Mucinex DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Navajo Manufacturing Company Inc. | NDA | Current |
| 67751-171 | Mucinex DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Navajo Manufacturing Company Inc. | NDA | Current |
| 68196-073 | Guaifenesin and Dextromethorphan Hydrobromide | Guaifenesin and Dextromethorphan Hydrobromide | SAM'S WEST INC | NDA | Current |
| 68788-6340 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6340 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6340 | Mucinex DM | Guaifenesin and Dextromethorphan Hydrobromide | Preferred Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79333 | SUPPL | 2024-08-08 |
| 79332 | SUPPL | 2024-08-08 |
| 66338 | SUPPL | 2021-02-23 |
| 66332 | SUPPL | 2021-02-23 |
| 64277 | SUPPL | 2020-08-13 |
| 57407 | SUPPL | 2019-02-01 |
| 50585 | SUPPL | 2017-12-04 |
| 50584 | SUPPL | 2017-12-01 |
| 28255 | SUPPL | 2014-03-07 |
| 5868 | SUPPL | 2014-03-07 |
| 5867 | SUPPL | 2009-04-09 |
| 37344 | SUPPL | 2007-09-07 |
| 28254 | SUPPL | 2007-09-07 |
| 5866 | SUPPL | 2006-01-30 |
| 42236 | ORIG | 2005-10-06 |
| 5865 | SUPPL | 2005-01-26 |
| 15881 | ORIG | 2004-05-04 |
| 28253 | ORIG | 2004-05-03 |