FDA.reportPublic FDA data

Application 091135

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 30MG HYDROBROMIDE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091135-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2012-05-25a50c72e98297…

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 · 45 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-92d1708a62fe2026-09-16WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
Good Sense Cough DMDEXTROMETHORPHAN POLISTIREXL. Perrigo Company5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea2026-08-27WarningsExact identifier
application applno (ANDA): 091135
application number: ANDA091135
ndc (product): 0113-0958
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
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
ndc (product): 11673-114
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
ndc (product): 0904-6312
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 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
ndc (product): 36800-494
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
ndc (product): 0363-0899
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 203 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-7384basic care cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0958Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0958Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-520Signature Care Cough Reliefdextromethorphan polistirexSafewayANDACurrent
21130-890signature care childrens 12 hour cough reliefDextromethorphan polistirexSafewayANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-958Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-958Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-552Topcare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48434ORIG2017-05-17
9320ORIG2012-05-30