Application 209692
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 30MG;600MG | No | No |
| 002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | TABLET, EXTENDED RELEASE;ORAL | 60MG;1.2GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ||
| A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | FSA Store Inc. (Caring Mills) | 57ade7e9-1c68-456c-8853-5acdef7e8f0e | 2024-02-05 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | A-S Medication Solutions | 786607e9-ee2d-4510-8556-857032e4053f | 2023-11-22 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | ee34af0f-61ba-49fa-81e0-20da4c582368 | 2023-05-03 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Strategic Sourcing Services LLC | af359aca-ec58-47cb-843a-2def1a09a09a | 2023-04-10 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Strategic Sourcing Services LLC | 5eb5f84f-4cb8-4552-b73d-c2b27657fa15 | 2023-04-06 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Care One (Retail Business Services, LLC.) | eb3ef974-4e79-4065-a8c9-9307092da6b3 | 2022-10-21 | Warnings | 209692 ANDA209692 72476-733 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Care One (Retail Business Services, LLC.) | 93658f3c-1f57-41b5-acdc-ee7ee47656a3 | 2022-10-21 | Warnings | 209692 ANDA209692 72476-734 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Cardinal Health (Leader) 70000 | 04af43e6-6276-42ec-a902-3de22bc9fdea | 2022-10-20 | Warnings | 209692 ANDA209692 70000-0464 |
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 |
|---|---|---|---|---|---|
| 67091-345 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | WinCo Foods, LLC | ANDA | Current |
| 68016-674 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-674 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Chain Drug Consortium, LLC | ANDA | Current |
| 69256-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Harris Teeter, LLC | ANDA | Current |
| 69256-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Harris Teeter, LLC | ANDA | Current |
| 69256-834 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Harris Teeter, LLC | ANDA | Current |
| 69256-834 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Harris Teeter, LLC | ANDA | Current |
| 69842-933 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | CVS Pharmacy | ANDA | Current |
| 69842-933 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | CVS Pharmacy | ANDA | Current |
| 69842-933 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | CVS Pharmacy | ANDA | Current |
| 70000-0464 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0464 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0464 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0464 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0464 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0491 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0491 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0491 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 70000-0491 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Cardinal Health (Leader) 70000 | ANDA | Current |
| 72476-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Care One (Retail Business Services, LLC.) | ANDA | Current |
| 72476-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Care One (Retail Business Services, LLC.) | ANDA | Current |
| 72476-734 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Care One (Retail Business Services, LLC.) | ANDA | Current |
| 72476-734 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Care One (Retail Business Services, LLC.) | ANDA | Current |
| 72476-734 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Care One (Retail Business Services, LLC.) | ANDA | Current |
| 82501-7340 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Gobrands, Inc. (Goodnow) | ANDA | Current |