CareOne Cough DM
- Product NDC
- 41520-384
- 11-digit product format
- 415200384
- Labeler code
- 41520
- Product ID
- 41520-384_4bf5ba3b-de73-4f48-8c89-efb1ec42d5d7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2012-08-30
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 30 mg/5mL
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CareOne Cough DM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| a90f088a-9578-47a2-8f6e-0a9d32aafec6 | Product name | 1 | 20181030 |
| f6c90bdc-1674-455a-aadd-1b1b59e5edeb | Product name | 2 | 20181030 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| f1ec5c2f-d01e-a277-5826-c7eba86ed99b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41520-384-21 | CareOne Cough DM | 89 mL in 1 BOTTLE | SUSPENSION | 89 | 5 | |
| 41520-384-21 | CareOne Cough DM | 1 in 1 CARTON | SUSPENSION | 1 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Cough DM | DEXTROMETHORPHAN POLISTIREX | H E B | f8f225cd-a0f2-4991-828f-cc7549778235 | 2025-11-01 | Warnings | 091135 ANDA091135 |
| Topcare Cough DM | DEXTROMETHORPHAN POLISTIREX | Topco Associates LLC | d1740816-425d-4327-9cff-6ca5ce430d0c | 2025-10-31 | Warnings | 091135 ANDA091135 |
| Leader Cough DM | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | 4c99b5e3-cd79-4c54-ae37-3673c836e668 | 2025-10-31 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Publix Super Markets Inc | 5a71cad4-8816-47f4-840c-27765d377f0a | 2025-09-26 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | fb6fce1e-2dea-485c-be18-c6764454fe25 | 2025-09-26 | Warnings | 091135 ANDA091135 |
| cough dm childrens | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 8af9367e-aa0b-4f9e-a7df-737d5411bc3c | 2025-06-13 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | ATLANTIC BIOLOGICALS CORP. | 73aede9d-37dd-4aa5-a906-0e0c94cecff1 | 2025-05-12 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 3febf0e0-b587-495a-9608-3a2dfbc32791 | 2025-05-07 | Warnings | 091135 ANDA091135 |
| dextromethorphan polistirex extended release | DEXTROMETHORPHAN POLISTIREX | Bryant Ranch Prepack | bd415342-90e1-411b-b6c9-652e9532c611 | 2025-04-02 | Warnings | 091135 ANDA091135 |
| dextromethorphan polistirex extended release | DEXTROMETHORPHAN POLISTIREX | Padagis Israel Pharmaceuticals Ltd | 7a6b68eb-8fe0-447d-aed7-28432c45b58c | 2025-02-11 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | CVS Pharmacy | a9765a9b-3ae3-45bc-ab59-06ec5249e2c9 | 2025-02-11 | Warnings | 091135 ANDA091135 |
| Robitussin 12 Hour Cough Relief | DEXTROMETHORPHAN POLISTIREX | Haleon US Holdings LLC | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 2024-04-08 | Warnings | 091135 ANDA091135 |
| Childrens Robitussin 12 Hour Cough Relief | DEXTROMETHORPHAN POLISTIREX | Haleon US Holdings LLC | 6bcad434-5714-443c-ba83-ed534df9f20a | 2024-04-08 | Warnings | 091135 ANDA091135 |
| equaline cough dm | DEXTROMETHORPHAN POLISTIREX | United Natural Foods, Inc. dba UNFI | 16de32bb-1d02-470b-82b6-9b4366e19817 | 2023-07-24 | Warnings | 091135 ANDA091135 |
| signature care 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Safeway | 6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8 | 2023-06-08 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Walgreen Company | be67fb34-6ecb-4b45-9a67-3f78f4af8e36 | 2023-06-06 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Walgreen Company | c628923a-6771-4aba-9e2d-4795c9effb33 | 2023-04-04 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | CVS Pharmacy | cb71164f-e4bf-48b9-a8b1-f7271d38a588 | 2022-06-29 | Warnings | 091135 ANDA091135 |
| signature care childrens 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Safeway | 62d71572-d157-484a-8676-7ce6da413ee8 | 2022-06-01 | Warnings | 091135 ANDA091135 |
| basic care cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | 8127c389-c1e3-4f2e-b306-13587b5b50c4 | 2021-08-09 | Warnings | 091135 ANDA091135 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 2543912b-e6dd-46ca-8f0e-12603f6c28a7 | 5 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 2543912b-e6dd-46ca-8f0e-12603f6c28a7 | 5 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 2543912b-e6dd-46ca-8f0e-12603f6c28a7 | 5 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 2543912b-e6dd-46ca-8f0e-12603f6c28a7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41520-384-21 | 41520038421 | 1 BOTTLE in 1 CARTON (41520-384-21) / 89 mL in 1 BOTTLE | 1 bottle | 2012-08-30 | 0000-00-00 | No | No | Current |