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 145 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacyd40d6fd1-3f84-40ae-ab7e-04569eb416172024-10-30WarningsExact identifier
application number: M012
equaline nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI4e0c6ad6-81ef-4b0e-b2eb-44256faf73582024-10-30WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fbe2c0-7749-4c8a-e063-6394a90a7c6e2024-10-30WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC130e68d1-9048-49c1-beee-490eecaed2d92024-10-30WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company02f3e739-3153-412f-b2cd-6f01dcd5875b2024-10-30WarningsExact identifier
application number: M012
HealthWise Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcare25a19d3e-37b3-50d5-e063-6394a90a97d12024-10-29WarningsExact identifier
application number: M012
Antigrip FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23a03-6110-f595-e063-6394a90a70fe2024-10-29WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23e5e-302a-7b7f-e063-6294a90a04632024-10-29WarningsExact identifier
application number: M012
Antigrip Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPharmadel LLC25a26adf-fd90-bf57-e063-6294a90a40732024-10-29WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Le82dac83-2910-44dc-e053-2995a90a38e12024-10-29WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
application number: M012
Premier Value Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC46bf124a-a44f-4066-b936-852d46da8f402024-10-28WarningsExact identifier
application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
application number: M012
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
application number: M012
Premier Value Tussin Cough Long ActingDEXTROMETHORPHAN HBRChain Drug Consortium, LLC0e393287-5bb8-458b-98c4-55fa16674d062024-10-28WarningsExact identifier
application number: M012
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact 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