Leader Mucus DM
- Product NDC
- 70000-0372
- 11-digit product format
- 700000372
- Labeler code
- 70000
- Product ID
- 70000-0372_e61d17e0-8113-4c17-8628-a8e38d22312b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan HBr, guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- ANDA207602
- Marketing category
- ANDA
- Marketing start
- 2018-05-07
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1200 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70000-0372 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70000-0372 | 70000-0372-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70000-0372 | 70000-0372-2 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70000-0372-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70000-0372-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70000-0372-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70000-0372-2 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | ||
| A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 |
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 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 60MG;1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207602-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | 30MG;600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-03-05 | 782e0a99824c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0372-1 | EA - Each | 70000-0372 | 7383a5d8-0daf-4af2-baba-c6ae1ca1bb05 | 1 | 2018-11-06 |
| 70000-0372-2 | EA - Each | 70000-0372 | 5aadc25d-c165-436a-bd1a-72e67f349701 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0372 | LEADER MUCUS DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 2 | Legacy NDC | 20210618_73f9e9c8-3319-4916-a897-8db06e34562a.zip |
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 |
|---|---|---|---|---|---|---|
| RUGBY MUCUS RELIEF DM ER | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rugby Laboratories | 8090d561-0478-435d-ad6f-2334e1823bc3 | 2026-07-28 | Warnings | 207602 ANDA207602 |
| Good Sense Mucus DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | 34f26b33-af34-470a-b57e-921fbdcbd9af | 2026-07-13 | Warnings | 207602 ANDA207602 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | db57f6b3-30ca-4a65-9043-f61be24d9b50 | 2026-06-25 | Warnings | 207602 ANDA207602 |
| mucus relief DM MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN | Rite Aid Corporation | a5fd7378-fd7b-400b-a374-0f3bee37702d | 2026-06-03 | Warnings | 207602 ANDA207602 |
| mucus relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 84b5d83d-aea5-42ed-b20c-96d3b389c8c0 | 2026-05-27 | Warnings | 207602 ANDA207602 |
| mucus dm extended release | GUAIFENESIN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 1bc37ee4-df27-4358-b724-6b55406dbce6 | 2026-05-08 | Warnings | 207602 ANDA207602 |
| mucus dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | HyVee Inc | 6bce66d6-e76a-4273-aff9-7ee6adc18980 | 2026-03-18 | Warnings | 207602 ANDA207602 |
| MUCUS DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 4ffa61d9-d24d-4982-a318-1660b56704e6 | 2026-03-02 | Warnings | 207602 ANDA207602 |
| Good Sense Mucus DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Sportpharm LLC | 81fb0ce7-1b13-4b9d-8f98-671ffd9205c3 | 2026-02-23 | Warnings | 207602 ANDA207602 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1 | 2026-02-17 | Warnings | 207602 ANDA207602 |
| RUGBY MUCUS RELIEF DM ER | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | A-S Medication Solutions | 511a5d9b-16a6-481c-a3d3-bcba911ecc9d | 2026-02-11 | Warnings | 207602 ANDA207602 |
| Berkley and Jensen Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | d3b94cce-e6f3-43ec-a927-7b7183744433 | 2025-12-17 | Warnings | 207602 ANDA207602 |
| mucus dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution Inc | cb2b9828-1665-4b66-a59a-b9f9539b51b5 | 2025-09-17 | Warnings | 207602 ANDA207602 |
| GOOD NEIGHBOR PHARMACY MUCUS DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | f0aea945-1c18-4c6f-a7d1-6d56624011bb | 2025-09-12 | Warnings | 207602 ANDA207602 |
| good neighbor pharmacy mucus dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amerisource Bergen | f7925a6b-7029-4389-bf1b-8c0f5e79b950 | 2025-09-11 | Warnings | 207602 ANDA207602 |
| kirkland signature mucus dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | Costco Wholesale Company | d2151492-c6bb-42c7-887f-37ef3eab3460 | 2025-08-20 | Warnings | 207602 ANDA207602 |
| good sense mucus dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | L Perrigo Company | 654dc991-1984-43cc-a00e-0c85d910b323 | 2025-08-20 | Warnings | 207602 ANDA207602 |
| mucus dm extended release | GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE | CVS Pharmacy | 6c9540ae-aea1-4717-8dca-60850ebdb1b4 | 2025-08-04 | Warnings | 207602 ANDA207602 |
| Topcare Mucus DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | c12c68c3-c1bf-45dd-a311-fe1005189ec1 | 2025-07-16 | Warnings | 207602 ANDA207602 |
| Exchange Select Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Army & Air Force Exchange Service | 99a11bea-8cf5-4c5d-95b1-eaedccaf9e7d | 2025-07-03 | Warnings | 207602 ANDA207602 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70000-0372-1 | 70000037201 | 1 BOTTLE in 1 CARTON (70000-0372-1) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2018-05-07 | 0000-00-00 | No | No | Current |
| 70000-0372-2 | 70000037202 | 1 BOTTLE in 1 CARTON (70000-0372-2) > 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2018-05-07 | 0000-00-00 | No | No | Current |