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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209692-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209692-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-11-01 | 3a93d1ddd44b… |
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 49035-824 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 6d454e89-59ce-40dc-b0d2-3330a7df519f | 2026-04-15 | Warnings | 209692 ANDA209692 63941-734 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 344de7bb-de3b-4c15-a920-72d94e5e0e9f | 2026-03-18 | Warnings | 209692 ANDA209692 63941-733 |
| Mucus Relief DM Extended Release Caplets | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rugby Laboratories | 69cd399a-0103-4543-bb06-c7cccffe9cc4 | 2026-02-10 | Warnings | 209692 ANDA209692 0536-1161 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | P & L Development, LLC | a397799d-46a6-447b-9498-17436d218e29 | 2026-01-28 | Warnings | 209692 ANDA209692 59726-733 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2426bf76-19bf-4bfd-8f9e-3b348e4b5641 | 2025-11-11 | Warnings | 209692 ANDA209692 55910-733 |
| 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 0363-0733 |
| Mucus Relief DM Extended Release Caplets Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Walgreens | 11310cf8-ea34-47a2-b4d7-fe1131fef462 | 2025-08-28 | Warnings | 209692 ANDA209692 0363-0437 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 8467474f-6278-47d9-8228-451d08ddf983 | 2025-08-20 | Warnings | 209692 ANDA209692 11822-7340 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 035693ed-d720-430b-98f5-fe4b5dec5db6 | 2025-08-20 | Warnings | 209692 ANDA209692 11822-0733 |
| Mucus Relief DM Maximum Strength | GUAIFENESIN, DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | d6aae1a1-0ab9-4b26-9f62-b8761014bb35 | 2025-06-30 | Warnings | 209692 ANDA209692 |
| 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 65162-038 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Amneal Pharmaceuticals LLC | cfdbcdb0-531a-4d95-ac5d-64d6d034b252 | 2024-10-25 | Warnings | 209692 ANDA209692 65162-039 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | H E B | 20df2ffe-5281-4cd6-adb3-3a3d28788ef6 | 2024-08-02 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | H E B | bcc41783-9213-4a8e-b7db-75b4da08551d | 2024-08-02 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | H E B | 187097bf-37c8-4184-a2fd-1eff9147d370 | 2024-08-01 | Warnings | 209692 ANDA209692 |
| Mucus Relief DM | GUAIFENESIN DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 8c9909bc-48b8-41d7-afe8-123e611a1448 | 2024-05-16 | Warnings | 209692 ANDA209692 |
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 |
|---|---|---|---|---|---|
| 0363-0437 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0363-0437 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0363-0437 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0363-0733 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0363-0733 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0363-0733 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Walgreens | ANDA | Current |
| 0536-1161 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1161 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1161 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1161 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1213 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1213 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 0536-1213 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Rugby Laboratories, Inc. | ANDA | Current |
| 11673-833 | Mucus Relief DM Extended Release | Guaifenesin, Dextromethorphan HBr | TARGET Corporation | ANDA | Current |
| 11673-833 | Mucus Relief DM Extended Release | Guaifenesin, Dextromethorphan HBr | TARGET Corporation | ANDA | Current |
| 11673-833 | Mucus Relief DM Extended Release | Guaifenesin, Dextromethorphan HBr | TARGET Corporation | ANDA | Current |
| 11673-834 | Mucus Relief DM MAX | Dextromethorphan HBr, Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-834 | Mucus Relief DM MAX | Dextromethorphan HBr, Guaifenesin | TARGET Corporation | ANDA | Current |
| 11673-834 | Mucus Relief DM MAX | Dextromethorphan HBr, Guaifenesin | TARGET Corporation | ANDA | Current |
| 11822-0733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-0733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-0733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-0733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-0733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-7340 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-7340 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 11822-7340 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Rite Aid Corporation | ANDA | Current |
| 37012-729 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-729 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-729 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-730 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-730 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 37012-730 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Shopko Stores Operating Co., LLC. | ANDA | Current |
| 41250-633 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | MEIJER, INC. | ANDA | Current |
| 41250-633 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | MEIJER, INC. | ANDA | Current |
| 41250-934 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | MEIJER, INC. | ANDA | Current |
| 41250-934 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | MEIJER, INC. | ANDA | Current |
| 49035-824 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-824 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-825 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-825 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 50090-6020 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | A-S Medication Solutions | ANDA | Current |
| 55910-634 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-634 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-634 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-634 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-634 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 55910-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | Current |
| 59726-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | P & L Development, LLC | ANDA | Current |
| 59726-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | P & L Development, LLC | ANDA | Current |
| 59726-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | P & L Development, LLC | ANDA | Current |
| 59726-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | P & L Development, LLC | ANDA | Current |
| 59726-833 | Mucus DM Extended Release | Dextromethorphan Hydrobromide and Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-833 | Mucus DM Extended Release | Dextromethorphan Hydrobromide and Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-834 | Mucus DM Extended-Release | Dextromethorphan Hydrobromide and Guaifenesin | P & L Development, LLC | ANDA | Current |
| 59726-834 | Mucus DM Extended-Release | Dextromethorphan Hydrobromide and Guaifenesin | P & L Development, LLC | ANDA | Current |
| 62011-0423 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0423 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0424 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0424 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Strategic Sourcing Services LLC | ANDA | Current |
| 63868-870 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63868-870 | Mucus Relief DM Extended Release Caplets | Guaifenesin, Dextromethorphan HBr | QUALITY CHOICE (Chain Drug Marketing Association) | ANDA | Current |
| 63941-733 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63941-734 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 65162-038 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-038 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-038 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-038 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-039 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-039 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-039 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-039 | Guaifenesin and Dextromethorphan HBr | Guaifenesin and Dextromethorphan HBr | Amneal Pharmaceuticals LLC | ANDA | Current |
| 67091-344 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | WinCo Foods, LLC | ANDA | Current |
| 67091-344 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | WinCo Foods, LLC | ANDA | Current |
| 67091-344 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | WinCo Foods, LLC | ANDA | Current |
| 67091-345 | Mucus Relief DM | Guaifenesin, Dextromethorphan HBr | WinCo Foods, LLC | ANDA | Current |