leader cough dm
- Product NDC
- 37205-697
- 11-digit product format
- 372050697
- Labeler code
- 37205
- Product ID
- 37205-697_8c713434-3dbd-4c0e-ae3d-78d6ca0d3076
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2012-09-13
- Marketing end
- 2019-05-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 30 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 37205-697 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 37205-697 | 37205-697-21 | D | Discontinued by firm | 2026-10-05 |
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 | 37205-697-21 | 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 | 37205-697-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37205-697-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37205-697-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37205-697-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37205-697-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37205-697-21 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37205-697-21 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37205-697-21 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 37205-697-21 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 37205-697-21 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 37205-697-21 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091135-001 | DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-697-21 | ML - Milliliter | 37205-697 | 50da1009-bafc-41e3-8ff7-469ba0da627c | 1 | 2013-02-13 |
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 |
|---|---|---|---|---|---|---|
| basic care childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | dcfb71a1-2a5b-4847-a23d-bbe381badcf6 | 2021-07-20 | Warnings | 091135 ANDA091135 |
| Signature Care Cough Relief | DEXTROMETHORPHAN POLISTIREX | Safeway | f95d0519-e96b-45fe-974c-8fe6b9b8c88c | 2021-07-13 | Warnings | 091135 ANDA091135 |
| basic care childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | 5b7c2306-ad87-48b0-99b7-71427907db0c | 2021-03-23 | Warnings | 091135 ANDA091135 |
| basic care cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | a0f35883-9dd3-49e7-87ac-ce04561ad6c3 | 2021-03-09 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Kroger Company | d98aa017-88db-4fe6-a260-ad6f3d8e23ea | 2020-09-08 | Warnings | 091135 ANDA091135 |
| DG Health Cough DM | DEXTROMETHORPHAN POLISTIREX | Dolgencorp, LLC | 949e8907-860e-4f36-a840-d63d2bae3348 | 2020-07-13 | Warnings | 091135 ANDA091135 |
| equate cough dm | DEXTROMETHORPHAN POLISTIREX | Wal-Mart Stores Inc | 5f72c4ad-1c30-41ea-b39c-7f4bb3deced6 | 2020-07-08 | Warnings | 091135 ANDA091135 |
| Good Neighbor Pharmacy Cough DM ER | DEXTROMETHORPHAN POLISTIREX | Amerisource Bergen | 4b23739b-5fae-4348-a387-c23dcde90b8b | 2020-07-01 | Warnings | 091135 ANDA091135 |
| CareOne Cough DM | DEXTROMETHORPHAN POLISTIREX | American Sales Company | 2543912b-e6dd-46ca-8f0e-12603f6c28a7 | 2020-07-01 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Kroger Company | 95051fe4-b42d-4395-b8d0-6889cc6d2fab | 2020-05-28 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | CVS Pharmacy | 956f0bd4-3266-4754-9bd2-ac480e3bcbce | 2020-05-27 | Warnings | 091135 ANDA091135 |
| CareOne Cough DM | DEXTROMETHORPHAN POLISTIREX | American Sales Company | 42f67a3c-8cd7-44a6-8e54-08fb8449e8d7 | 2019-12-09 | Warnings | 091135 ANDA091135 |