Cough DM

Product NDC
11822-0958
11-digit product format
118220958
Labeler code
11822
Product ID
11822-0958_63a027a3-97fb-4660-9b1c-0095683e41ec
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-07-24
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

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-0958DDiscontinued by firm2026-08-17
excluded packagepackage11822-095811822-0958-1DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091135-001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f01610625f2…
2019-09-15 20:21 UTC2019-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0958-1Cough DM1 in 1 CARTONSUSPENSION16
11822-0958-1Cough DM89 mL in 1 BOTTLESUSPENSION896

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
TRAGACANTHINACTIVE INGREDIENT2944357O2OCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
TRIACETININACTIVE INGREDIENTXHX3C3X673COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0958COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [RITE AID CORPORATION]6Current NDC, Legacy NDC, 2 package rows20250122_9f632044-d96a-4c91-9588-0cb4337819ea.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.

Matched openFDA labels page 1 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC10f51748-17b1-459d-8cc6-acc4577290aa2026-08-20WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC43a90c58-8a7b-47cb-91ed-4afa3ec5dfb32026-08-13WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
12 hr relief cough dmDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED03c44e2f-d6e3-4c78-9c9a-92d1708a62fe2026-07-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Equate Cough DMDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc956fcc21-9e0f-41e3-9304-f379364a7d1c2026-06-26WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
leader childrens cough dmDEXTROMETHORPHAN POLISTIREXCardinal Health 110, LLC. dba Leader3a468feb-da54-4a2c-bfce-bfe99f77efc32026-06-25WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
CHILDRENS 12 HR COUGH RELIEFDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c2026-06-17WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
12 HR RELIEF COUGH DMDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd63fff6c-a1cd-4636-b1d3-ae83be40c3f72026-06-03WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
up and up 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXTarget Corporationa8acec73-dc66-444e-9438-370893cd51292026-05-11WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
COUGH DMDEXTROMETHORPHAN POLISTIREXSafeway58dab2f1-27b5-4522-bdc6-b710f20802eb2026-05-04WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXMajor Pharmaceuticalscdb5616e-0f04-4b9e-a82b-994e9ba3b5152026-04-13WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Leader Cough DMDEXTROMETHORPHAN POLISTIREXCardinal Health 110, LLC. dba Leadera07b70d0-3842-4ea6-abb4-95b4638d5e552026-04-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXRite Aid Corporation0b92c230-e86f-4e2f-9330-6a85de61eaf02026-03-24WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXHyVee Incce7dafc6-1c23-40d2-94d0-2568298fd7ff2026-03-06WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXHyVee Inc20c10d74-0435-4e8a-acd7-5af1f8382c282026-01-27WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
DG Health Cough DMDEXTROMETHORPHAN POLISTIREXDolgencorp Inc648ca6b2-d31f-4941-baad-0f2accd30a9e2026-01-21WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc6bdfa599-7898-4c05-927c-52fb82e0e6862026-01-02WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
TopCare Cough DMDEXTROMETHORPHAN POLISTIREXTopco Associates LLC490f695c-e60f-43db-b3f3-a9ffbb2906dd2025-12-10WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
foster and thrive 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXStrategic Sourcing Services LLCdb2e79f7-827f-45da-85ba-f3a7742510702025-12-09WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
childrens cough dmDEXTROMETHORPHAN POLISTIREXWalgreen Company317ab8e0-c329-4d4e-9fd0-4bff4e1504cd2025-11-20WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
foster and thrive 12 hour cough reliefDEXTROMETHORPHAN POLISTIREXStrategic Sourcing Services LLC043072e5-b92d-4fed-bfd8-aea07956806b2025-11-14WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN9f632044-d96a-4c91-9588-0cb4337819ea6
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD9f632044-d96a-4c91-9588-0cb4337819ea6
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY9f632044-d96a-4c91-9588-0cb4337819ea6
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY9f632044-d96a-4c91-9588-0cb4337819ea6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0958-1118220958011 BOTTLE in 1 CARTON (11822-0958-1) / 89 mL in 1 BOTTLE1 bottle2013-07-240000-00-00NoNoCurrent