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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 782e0a99824c… |
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 Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 3850544d-0d25-429e-98a9-5c4ad6cfd222 | 2026-07-14 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 6d454e89-59ce-40dc-b0d2-3330a7df519f | 2026-04-15 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 344de7bb-de3b-4c15-a920-72d94e5e0e9f | 2026-03-18 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 59c338a0-8dc9-43a7-b8df-c26ae475def3 | 2026-03-18 | Warnings | 209692 ANDA209692 69842-933 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | e24fd894-5dee-4f46-aafa-fbf9f0b166fd | 2026-02-10 | Warnings | 209692 ANDA209692 70000-0491 |
| Maximum Strength Guaifenesin DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rugby Laboratories | 2c9515f8-3120-4dbb-a7fc-d89fc5727148 | 2026-02-10 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rugby Laboratories | 69cd399a-0103-4543-bb06-c7cccffe9cc4 | 2026-02-10 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | P & L Development, LLC | a397799d-46a6-447b-9498-17436d218e29 | 2026-01-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2426bf76-19bf-4bfd-8f9e-3b348e4b5641 | 2025-11-11 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | ebc1a915-f643-4878-9d7a-67a9c6a26b20 | 2025-10-30 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | b60d1cc6-086c-4483-a101-c5f8d6000969 | 2025-10-29 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Walgreens | be5ab61a-abd6-4dee-9607-2f1e2c47b2dc | 2025-08-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Extended Release Caplets Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Walgreens | 11310cf8-ea34-47a2-b4d7-fe1131fef462 | 2025-08-28 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 8467474f-6278-47d9-8228-451d08ddf983 | 2025-08-20 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 035693ed-d720-430b-98f5-fe4b5dec5db6 | 2025-08-20 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | d6aae1a1-0ab9-4b26-9f62-b8761014bb35 | 2025-06-30 | Warnings | 209692 ANDA209692 68016-674 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | ATLANTIC BIOLOGICALS CORP. | 308f50dd-e8d6-0264-e063-6394a90afa68 | 2025-06-27 | Warnings | 209692 ANDA209692 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amneal Pharmaceuticals LLC | 5760a828-1c28-4272-a7b7-ac98466aa294 | 2024-10-25 | Warnings | 209692 ANDA209692 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amneal Pharmaceuticals LLC | cfdbcdb0-531a-4d95-ac5d-64d6d034b252 | 2024-10-25 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | H E B | 20df2ffe-5281-4cd6-adb3-3a3d28788ef6 | 2024-08-02 | Warnings | 209692 ANDA209692 |
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 |