Robitussin 12 Hour Cough Relief
- Product NDC
- 0031-8753
- 11-digit product format
- 000318753
- Labeler code
- 0031
- Product ID
- 0031-8753_159a0a07-055f-e1e2-e063-6394a90a9a37
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- ANDA091135
- Marketing category
- ANDA
- Marketing start
- 2015-07-01
- 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
- 2026-12-31
- 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091135-001 | DEXTROMETHORPHAN POLISTIREX | EQ 30MG HYDROBROMIDE/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2012-05-25 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Robitussin 12 Hour Cough Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1373045 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0031-8753-03 | Robitussin 12 Hour Cough Relief | 89 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 89 | 7 | |
| 0031-8753-03 | Robitussin 12 Hour Cough Relief | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8753-03 | ML - Milliliter | 0031-8753 | 5cea1c5d-dd67-4074-97a6-49bbd9062067 | 1 | 2019-08-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8753 | ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240410_5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5.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 |
|---|---|---|---|---|---|---|
| 12 hr relief cough dm | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 03c44e2f-d6e3-4c78-9c9a-92d1708a62fe | 2026-07-08 | Warnings | 091135 ANDA091135 |
| Equate Cough DM | DEXTROMETHORPHAN POLISTIREX | Wal-Mart Stores Inc | 956fcc21-9e0f-41e3-9304-f379364a7d1c | 2026-06-26 | Warnings | 091135 ANDA091135 |
| leader childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | 3a468feb-da54-4a2c-bfce-bfe99f77efc3 | 2026-06-25 | Warnings | 091135 ANDA091135 |
| CHILDRENS 12 HR COUGH RELIEF | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c | 2026-06-17 | Warnings | 091135 ANDA091135 |
| 12 HR RELIEF COUGH DM | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d63fff6c-a1cd-4636-b1d3-ae83be40c3f7 | 2026-06-03 | Warnings | 091135 ANDA091135 |
| up and up 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Target Corporation | a8acec73-dc66-444e-9438-370893cd5129 | 2026-05-11 | Warnings | 091135 ANDA091135 |
| COUGH DM | DEXTROMETHORPHAN POLISTIREX | Safeway | 58dab2f1-27b5-4522-bdc6-b710f20802eb | 2026-05-04 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Major Pharmaceuticals | cdb5616e-0f04-4b9e-a82b-994e9ba3b515 | 2026-04-13 | Warnings | 091135 ANDA091135 |
| Leader Cough DM | DEXTROMETHORPHAN POLISTIREX | Cardinal Health 110, LLC. dba Leader | a07b70d0-3842-4ea6-abb4-95b4638d5e55 | 2026-04-08 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Rite Aid Corporation | 0b92c230-e86f-4e2f-9330-6a85de61eaf0 | 2026-03-24 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | ce7dafc6-1c23-40d2-94d0-2568298fd7ff | 2026-03-06 | Warnings | 091135 ANDA091135 |
| cough dm | DEXTROMETHORPHAN POLISTIREX | HyVee Inc | 20c10d74-0435-4e8a-acd7-5af1f8382c28 | 2026-01-27 | Warnings | 091135 ANDA091135 |
| DG Health Cough DM | DEXTROMETHORPHAN POLISTIREX | Dolgencorp Inc | 648ca6b2-d31f-4941-baad-0f2accd30a9e | 2026-01-21 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | Meijer Distribution Inc | 6bdfa599-7898-4c05-927c-52fb82e0e686 | 2026-01-02 | Warnings | 091135 ANDA091135 |
| TopCare Cough DM | DEXTROMETHORPHAN POLISTIREX | Topco Associates LLC | 490f695c-e60f-43db-b3f3-a9ffbb2906dd | 2025-12-10 | Warnings | 091135 ANDA091135 |
| foster and thrive 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Strategic Sourcing Services LLC | db2e79f7-827f-45da-85ba-f3a774251070 | 2025-12-09 | Warnings | 091135 ANDA091135 |
| childrens cough dm | DEXTROMETHORPHAN POLISTIREX | Walgreen Company | 317ab8e0-c329-4d4e-9fd0-4bff4e1504cd | 2025-11-20 | Warnings | 091135 ANDA091135 |
| foster and thrive 12 hour cough relief | DEXTROMETHORPHAN POLISTIREX | Strategic Sourcing Services LLC | 043072e5-b92d-4fed-bfd8-aea07956806b | 2025-11-14 | Warnings | 091135 ANDA091135 |
| good sense cough dm | DEXTROMETHORPHAN POLISTIREX | L. Perrigo Company | 1b11b25b-2716-45f9-830f-ddf622366e60 | 2025-11-02 | Warnings | 091135 ANDA091135 |
| Cough DM | DEXTROMETHORPHAN POLISTIREX | H E B | f8f225cd-a0f2-4991-828f-cc7549778235 | 2025-11-01 | 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 | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 7 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 7 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 7 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8753-03 | 00031875303 | 1 BOTTLE in 1 CARTON (0031-8753-03) / 89 mL in 1 BOTTLE | 1 bottle | 2015-07-01 | 0000-00-00 | No | No | Current |