FDA.reportPublic FDA data

Mucinex

Product NDC
72854-001
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-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
2026-09-14 22:38:342026-08N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-2284e616aacf4f…
2026-08-18 06:07:402026-07N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22caaa826d4ba7…
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
2026-09-14 22:38:342026-08N217338-001112785062036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001122572182036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001123701892036-10-11Drug product2026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N217338-001112785062036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001122572182036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001123701892036-10-11Drug product2026-04-07caaa826d4ba7…
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…

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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
NAPROXEN SODIUM110 mg/1
GUAIFENESIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
9TN87S3A3CInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2744506Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49f1f415-8017-0974-e063-6294a90a8918Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

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
ndc (product): 72854-001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612689{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) } PackGPCK38571853-992f-9998-e063-6394a90a85813
26126891 daytime (acetaminophen 325 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN38571853-992f-9998-e063-6394a90a85813
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSN38571853-992f-9998-e063-6394a90a85813
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN38571853-992f-9998-e063-6394a90a85813
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD38571853-992f-9998-e063-6394a90a85813
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD38571853-992f-9998-e063-6394a90a85813
26126891 daytime (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY38571853-992f-9998-e063-6394a90a85813
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSY38571853-992f-9998-e063-6394a90a85813
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY38571853-992f-9998-e063-6394a90a85813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72854-001-16728540001162 BLISTER PACK in 1 CARTON (72854-001-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2026-06-01NoNoCurrent
72854-001-32728540001324 BLISTER PACK in 1 CARTON (72854-001-32) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2026-06-01NoNoCurrent
72854-001-50728540001505 BLISTER PACK in 1 CARTON (72854-001-50) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2026-06-01NoNoCurrent