FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX

Product NDC
11673-033
11-digit product format
116730033
Labeler code
11673
Product ID
11673-033_a1e0dc15-5252-43a6-98b0-6200cf5f2adb
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN POLISTIREX
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
ANDA218417
Marketing category
ANDA
Marketing start
2026-10-07
Substance
DEXTROMETHORPHAN
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
2027-12-31
Current FDA listing
Yes

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
A218417-001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218417-001DEXTROMETHORPHAN POLISTIREXEQ 30MG HYDROBROMIDE/5MLSUSPENSION, EXTENDED RELEASE / ORAL2026-04-15a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROMETHORPHAN POLISTIREX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXAurohealth LLCfc328034-ad2a-4f7d-81cf-f4da4e64f5d72026-05-13WarningsExact identifier
application applno (ANDA): 218417
application number: ANDA218417
DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXAurohealth LLC0fb8cdfc-3fa0-4773-813a-04c82b003bdf2026-05-13WarningsExact identifier
application applno (ANDA): 218417
application number: ANDA218417
DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXAurohealth LLC4fde00af-3824-44f1-8a5f-d88518e0a8c82026-05-04WarningsExact identifier
application applno (ANDA): 218417
application number: ANDA218417
DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXAurohealth LLC759acdcd-d8d0-41d0-8b80-7f81fe196a9f2026-05-04WarningsExact identifier
application applno (ANDA): 218417
application number: ANDA218417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-033-05116730033051 BOTTLE in 1 CARTON (11673-033-05) / 148 mL in 1 BOTTLE1 bottle2026-10-07NoNoCurrent