Health Mart Cough DM

Product NDC
62011-0198
11-digit product format
620110198
Labeler code
62011
Product ID
62011-0198_c9b3eecb-7fe3-4a5b-bb0e-cb45a6dee801
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-06-18
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0198DDiscontinued by firm2026-10-05
excluded packagepackage62011-019862011-0198-1DDiscontinued by firm2026-10-05

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.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0198-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0198-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0198-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0198-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0198-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0198-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0198-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0198-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0198-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0198-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0198-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62011-0198-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-2584e616aacf4f…
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…

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 table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0198-1ML - Milliliter62011-0198ca79926d-1af1-4ad7-8ac8-96afe4668a3d12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
SUCROSEINACTIVE INGREDIENTC151H8M554HEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
TRIACETININACTIVE INGREDIENTXHX3C3X673HEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHEALTH MART COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [MCKESSON]1

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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCdcfb71a1-2a5b-4847-a23d-bbe381badcf62021-07-20WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Signature Care Cough ReliefDEXTROMETHORPHAN POLISTIREXSafewayf95d0519-e96b-45fe-974c-8fe6b9b8c88c2021-07-13WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
basic care childrens cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC5b7c2306-ad87-48b0-99b7-71427907db0c2021-03-23WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
basic care cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLCa0f35883-9dd3-49e7-87ac-ce04561ad6c32021-03-09WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
cough dmDEXTROMETHORPHAN POLISTIREXKroger Companyd98aa017-88db-4fe6-a260-ad6f3d8e23ea2020-09-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
DG Health Cough DMDEXTROMETHORPHAN POLISTIREXDolgencorp, LLC949e8907-860e-4f36-a840-d63d2bae33482020-07-13WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
equate cough dmDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc5f72c4ad-1c30-41ea-b39c-7f4bb3deced62020-07-08WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Good Neighbor Pharmacy Cough DM ERDEXTROMETHORPHAN POLISTIREXAmerisource Bergen4b23739b-5fae-4348-a387-c23dcde90b8b2020-07-01WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company2543912b-e6dd-46ca-8f0e-12603f6c28a72020-07-01WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXKroger Company95051fe4-b42d-4395-b8d0-6889cc6d2fab2020-05-28WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacy956f0bd4-3266-4754-9bd2-ac480e3bcbce2020-05-27WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company42f67a3c-8cd7-44a6-8e54-08fb8449e8d72019-12-09WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0198-1620110198011 BOTTLE in 1 CARTON (62011-0198-1) > 89 mL in 1 BOTTLE1 bottle2013-06-180000-00-00NoNoCurrent