FDA.reportPublic FDA data

Mucinex Sinus Max Clear and Cool

Product NDC
72854-211
11-digit product format
728540211
Labeler code
72854
Product ID
72854-211_37de8769-b540-b01f-e063-6394a90a5a2a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Guaifenesin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RB Health (US) LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
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
2026-12-31
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 Sinus Max Clear and Cool
Listing expiration
2026-12-31

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
707195Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37de813a-54b7-672a-e063-6294a90a374eAvailable 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
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
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
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
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
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
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-211-08Mucinex Sinus Max Clear and Cool1 in 1 CARTONCAPSULE, LIQUID FILLED14
72854-211-08Mucinex Sinus Max Clear and Cool8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
72854-211-16Mucinex Sinus Max Clear and Cool1 in 1 CARTONCAPSULE, LIQUID FILLED14
72854-211-16Mucinex Sinus Max Clear and Cool16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED164
72854-211-16Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1325 mg3
72854-211-16Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool1 in 1 CARTONCAPSULE, LIQUID FILLED325 mg3
72854-211-08Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1325 mg2
72854-211-08Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool1 in 1 CARTONCAPSULE, LIQUID FILLED325 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-211MUCINEX RAPID CLEAR PAIN, HEADACHE, AND MUCUS CONGESTION AND SINUS MAX CLEAR AND COOL (OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN) KIT [RB HEALTH (US) LLC]1Current NDC20250519_33f0d9bb-c67d-92ba-e063-6294a90a9943.zip

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 88 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MULTI-SYMPTOM COLDDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb1fae7cc-4033-44bc-aa7c-ca3ceea51c7d2025-11-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb2c0692c-ed0b-4fcf-b88d-59a788b124c62025-11-14WarningsExact identifier
application number: M012
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.c1873a4c-661f-4896-bcc0-f6d3a655de942025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
application number: M012
equaline allergyDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI8e4eb1eb-5b55-4531-94d2-998425ec80ed2025-11-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.7a78f24b-7c23-4318-99dc-90c05db185b12025-11-13WarningsExact identifier
application number: M012
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
application number: M012
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
application number: M012
4 Way Fast ActingPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa8fc41c7-4425-41b8-b1c6-eb22ac0547342025-11-12WarningsExact identifier
application number: M012
Quality Choice Vapor SteamCAMPHOR (SYNTHETIC)Chain Drug Marketing Association, Inc.1f1e6be5-d407-330c-e063-6294a90a4e802025-11-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN37de813a-54b7-672a-e063-6294a90a374e4
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD37de813a-54b7-672a-e063-6294a90a374e4
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY37de813a-54b7-672a-e063-6294a90a374e4
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN373e0d75-8def-4b98-e063-6394a90a5e473
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN373e0d75-8def-4b98-e063-6394a90a5e473
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD373e0d75-8def-4b98-e063-6394a90a5e473
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD373e0d75-8def-4b98-e063-6394a90a5e473
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY373e0d75-8def-4b98-e063-6394a90a5e473
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY373e0d75-8def-4b98-e063-6394a90a5e473
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN33f0d9bb-c67d-92ba-e063-6294a90a99432
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN33f0d9bb-c67d-92ba-e063-6294a90a99432
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD33f0d9bb-c67d-92ba-e063-6294a90a99432
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD33f0d9bb-c67d-92ba-e063-6294a90a99432
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY33f0d9bb-c67d-92ba-e063-6294a90a99432
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY33f0d9bb-c67d-92ba-e063-6294a90a99432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72854-211-08728540211081 BLISTER PACK in 1 CARTON (72854-211-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2025-06-01NoNoCurrent
72854-211-16728540211161 BLISTER PACK in 1 CARTON (72854-211-16) / 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2025-06-01NoNoCurrent