FDA.reportPublic FDA data

Mucinex Fast-Max Recharge Nighttime Cold and Flu

Product NDC
72854-167
11-digit product format
728540167
Labeler code
72854
Product ID
72854-167_5242a8df-8eed-5372-e063-6294a90aeafa
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Triprolidine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
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

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 Fast-Max Recharge Nighttime Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
TRIPROLIDINE HYDROCHLORIDE2.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2173667Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bae240c-70ce-e9c2-e063-6394a90a5f3dAvailable 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
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct 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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-167-66Mucinex Fast-Max Recharge Nighttime Cold and Flu180 mL in 1 BOTTLESOLUTION1802

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 22 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyd1657403-b953-4db1-9a86-343e9e769a1a2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company04dc3835-64be-d9e4-e063-6394a90a85992026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company1a01b294-a5ee-ab35-e063-6394a90a4a1a2026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9b3bbb-4494-065d-e063-6294a90afcd22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9a6d65-f849-af0a-e063-6394a90ae4352026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company1a01d4f7-37ed-bb92-e063-6294a90a208c2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company326ed27d-cbfa-5513-e063-6394a90a41bf2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids and Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2d430264-074d-fb22-e063-6294a90a57f62026-06-22WarningsExact identifier
application number: M012
DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINThe Procter & Gamble Manufacturing Companyef6e8503-d268-291b-e053-2995a90aec8f2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4147ff00-8e21-7335-e054-00144ff88e882026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN51021c69-d92b-0504-e063-6294a90a94e72026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil SINUS PAIN and HEADACHEACETAMINOPHEN, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4c4ca296-ea6c-1f19-e063-6294a90a81612026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company32bea3dc-9889-22dd-e063-6394a90afa1b2026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
Sinus and Congestion Non-DrowsyPSEUDOEPHEDRINE HCLWal-Mart Stores Inccbdac7ad-3904-4a85-91a9-863f6f06503d2026-06-22WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN4bae240c-70ce-e9c2-e063-6394a90a5f3d2
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD4bae240c-70ce-e9c2-e063-6394a90a5f3d2
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY4bae240c-70ce-e9c2-e063-6394a90a5f3d2
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY4bae240c-70ce-e9c2-e063-6394a90a5f3d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72854-167-6672854016766180 mL in 1 BOTTLE (72854-167-66) 180 ml2026-03-01NoNoCurrent