FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX

Product NDC
58602-611
11-digit product format
586020611
Labeler code
58602
Product ID
58602-611_e568400c-98ea-4f20-be34-1fb3e05bb72b
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN POLISTIREX
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA218417
Marketing category
ANDA
Marketing start
2026-04-15
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 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
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
2026-08-18 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…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7355X3ROTSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1373045Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
759acdcd-d8d0-41d0-8b80-7f81fe196a9fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-611-05DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE13
58602-611-05DEXTROMETHORPHAN POLISTIREX89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE893
58602-611-06DEXTROMETHORPHAN POLISTIREX148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1483
58602-611-06DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE13

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
ndc (product): 58602-611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN759acdcd-d8d0-41d0-8b80-7f81fe196a9f3
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD759acdcd-d8d0-41d0-8b80-7f81fe196a9f3
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY759acdcd-d8d0-41d0-8b80-7f81fe196a9f3
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY759acdcd-d8d0-41d0-8b80-7f81fe196a9f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-611-05586020611051 BOTTLE in 1 CARTON (58602-611-05) / 89 mL in 1 BOTTLE1 bottle2026-04-15NoNoCurrent
58602-611-06586020611061 BOTTLE in 1 CARTON (58602-611-06) / 148 mL in 1 BOTTLE1 bottle2026-04-15NoNoCurrent