Equate Cough DM

Product NDC
49035-958
Requested package NDC
49035-958-28
11-digit product format
490350958
Labeler code
49035
Product ID
49035-958_925a4569-b64a-4f3c-840f-f89fa291d8a4
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-08-20
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-95849035-958-28DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-958-28ML - Milliliter49035-95832847fec-ec53-418d-ad21-120b0744076c12018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
TRAGACANTHINACTIVE INGREDIENT2944357O2OEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]2

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 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
good sense cough dmDEXTROMETHORPHAN POLISTIREXL. Perrigo Company1b11b25b-2716-45f9-830f-ddf622366e602025-11-02WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Cough DMDEXTROMETHORPHAN POLISTIREXH E Bf8f225cd-a0f2-4991-828f-cc75497782352025-11-01WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-958-28490350958281 BOTTLE in 1 CARTON (49035-958-28) > 148 mL in 1 BOTTLE1 bottle2013-08-200000-00-00NoNoCurrent