FDA.reportPublic FDA data

Mucinex Fast-Max Cold, Flu and Sore Throat

Product NDC
72854-162
11-digit product format
728540162
Labeler code
72854
Product ID
72854-162_5242a71b-83b2-5e9f-e063-6394a90a5b4d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
ACETAMINOPHEN; GUAIFENESIN
Active strength
325; 200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Cold, Flu and Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
602617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50b140ad-aba2-ce6b-e063-6294a90ae2f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-162-20Mucinex Fast-Max Cold, Flu and Sore Throat10 in 1 BLISTER PACKTABLET102
72854-162-20Mucinex Fast-Max Cold, Flu and Sore Throat2 in 1 CARTONTABLET22

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 38 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
application number: M012
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
application number: M012
Childrens Daytime MucusDEXTROMETHORPHAN HBRWalgreens7a55b7e1-1054-421e-847e-5e4d90d1aebb2026-04-15WarningsExact identifier
application number: M012
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
application number: M012
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
application number: M012
Daytime Nighttime ChewableDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreens9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c62026-04-15WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4f7090f4-89c9-c3da-e063-6294a90a47162026-04-14WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLidl US LLC00f89eee-0edc-40dc-9297-8645afb910042026-04-14WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8647c136-a323-453a-8f57-e66938bbf6392026-04-14WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLWalgreen Company48387b95-8240-4d6e-842b-cc29cc18709c2026-04-13WarningsExact identifier
application number: M012
Sinufrin Plus No Drip DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc4f06c732-1f9f-bfc6-e063-6394a90a53f52026-04-13WarningsExact identifier
application number: M012
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLPublix Super Markets Incf2263e38-f686-45ed-bf85-b47f5e1aa9822026-04-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602617acetaminophen 325 MG / guaiFENesin 200 MG Oral TabletPSN50b140ad-aba2-ce6b-e063-6294a90ae2f82
602617acetaminophen 325 MG / guaifenesin 200 MG Oral TabletSCD50b140ad-aba2-ce6b-e063-6294a90ae2f82
602617APAP 325 MG / guaifenesin 200 MG Oral TabletSY50b140ad-aba2-ce6b-e063-6294a90ae2f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72854-162-20728540162202 BLISTER PACK in 1 CARTON (72854-162-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2025-04-01NoNoCurrent