FDA.reportPublic FDA data

Mucus Relief Sinus Severe Congestion Relief

Product NDC
37808-367
11-digit product format
378080367
Labeler code
37808
Product ID
37808-367_25007dfb-d0ee-47b9-e063-6394a90a51c7
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HEB
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-01
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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
Mucus Relief Sinus Severe Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9cbb3ab1-5f32-421e-9f28-d99be9447e9fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-367-02Mucus Relief Sinus Severe Congestion Relief2 in 1 CARTONTABLET, COATED23
37808-367-02Mucus Relief Sinus Severe Congestion Relief10 in 1 BLISTER PACKTABLET, COATED103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-367MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB]3Current NDC, Legacy NDC, 2 package rows20241023_9cbb3ab1-5f32-421e-9f28-d99be9447e9f.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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
application number: M012
SKAPEMED ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a208a1f-f6e8-0b4a-e063-6294a90a10c82026-07-21WarningsExact identifier
application number: M012
SERYNTH FAST RELIEF NASALNAPHAZOLINE HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4abdc0-aded-1b8a-e063-6394a90a9b562026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d0c03-7d8f-76cb-e063-6394a90a938c2026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
application number: M012
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
application number: M012
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC17639c3b-5d36-41f5-bd0d-da29075abd092026-07-21WarningsExact identifier
application number: M012
NATUHEAL ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a470b9e-c83f-fb20-e063-6294a90a2f132026-07-20WarningsExact identifier
application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1c444202-19e9-8d04-e063-6394a90a92942026-07-20WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)40e0b17a-5704-4203-8f0a-11b2fcf81f8f2026-07-17WarningsExact identifier
application number: M012
Equate Daytime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.ee1ef41d-b8be-42f3-9918-ccf1c0a802412026-07-17WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsExact identifier
application number: M012
BEST CHOICE No DripALLERGY SINUSBEST CHOICE (VALU MERCHANDISERS COMPANY)d5f95b56-8201-4d97-82ab-e23761bfe7202026-07-17WarningsExact identifier
application number: M012
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsExact identifier
application number: M012
Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0839c07b-f692-4af1-85b8-da60fb281d492026-07-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN9cbb3ab1-5f32-421e-9f28-d99be9447e9f3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD9cbb3ab1-5f32-421e-9f28-d99be9447e9f3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY9cbb3ab1-5f32-421e-9f28-d99be9447e9f3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY9cbb3ab1-5f32-421e-9f28-d99be9447e9f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-367-02378080367022 BLISTER PACK in 1 CARTON (37808-367-02) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-04-010000-00-00NoNoCurrent