Home NDC 72854-001-16 Mucinex
Product NDC 72854-001
Requested package NDC 72854-001-16
11-digit product format 728540001
Labeler code 72854
Product ID 72854-001_53490589-6b93-42b2-e063-6394a90a3c02
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Reckitt Benckiser LLC
Application NDA217338
Marketing category NDA
Marketing start 2026-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; NAPROXEN SODIUM; GUAIFENESIN
Active strength 30; 110; 600 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Nonsteroidal Anti-inflammatory Drug [EPC], 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217338-001 MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM 30MG;600MG;110MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-12-22
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217338-001 11278506 2036-10-11 Drug product 2026-04-07 N217338-001 12257218 2036-10-11 Drug product 2026-04-07 N217338-001 12370189 2036-10-11 Drug product 2026-04-07
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N217338-001 MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM 30MG;600MG;110MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217338-001 MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM 30MG;600MG;110MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217338-001 MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM 30MG;600MG;110MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-12-22 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217338-001 MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM 30MG;600MG;110MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-12-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217338-001 11278506 2036-10-11 Drug product 2026-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217338-001 12257218 2036-10-11 Drug product 2026-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217338-001 12370189 2036-10-11 Drug product 2026-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217338-001 11278506 2036-10-11 Drug product 2026-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217338-001 12257218 2036-10-11 Drug product 2026-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217338-001 12370189 2036-10-11 Drug product 2026-04-07 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217338-001 11278506 2036-10-11 Drug product 2026-04-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217338-001 12257218 2036-10-11 Drug product 2026-04-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217338-001 12370189 2036-10-11 Drug product 2026-04-07 a50c72e98297…
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 Mucinex
Brand name suffix 12HR Cold and Fever Multi-Symptom
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1 NAPROXEN SODIUM 110 mg/1 GUAIFENESIN 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 9TN87S3A3C Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2744506 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72854-001-16 72854000116 2 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 blister pack 2026-06-01 No No Current