FDA.reportPublic FDA data

Application 217338

Type
NDA
Sponsor
RB HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUMTABLET, EXTENDED RELEASE;ORAL30MG;600MG;110MGYesYes

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
N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217338-001112785062036-10-11Drug product2026-04-07
N217338-001122572182036-10-11Drug product2026-04-07
N217338-001123701892036-10-11Drug product2026-04-07

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
2026-02-19 14:30 UTC2026-02N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001112785062036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001122572182036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001123701892036-10-11Drug product2026-04-07a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex 12HR Cold and Fever Multi-SymptomNAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC49f1f415-8017-0974-e063-6294a90a89182026-06-02WarningsExact identifier
application applno (NDA): 217338
application number: NDA217338

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85617ORIG 2026-04-01
84544ORIG 2025-12-23
84542ORIG 2025-12-23