FDA.reportPublic FDA data

Mucus Relief Sinus Severe Congestion Relief

Product NDC
53943-167
11-digit product format
539430167
Labeler code
53943
Product ID
53943-167_24adffd4-5176-f5d5-e063-6294a90a7850
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-11
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
f171a389-8b22-429c-86bc-272156fdc1b7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-167-02Mucus Relief Sinus Severe Congestion Relief2 in 1 CARTONTABLET, COATED23
53943-167-02Mucus Relief Sinus Severe Congestion Relief10 in 1 BLISTER PACKTABLET, COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-167MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 2 package rows20241019_f171a389-8b22-429c-86bc-272156fdc1b7.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 171 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cough Mucus ReliefDEXTROMETHORPHANN HBR, GUAIFENESINDiscount Drug Mart2c27aca4-e1e2-419a-84c4-857718ca49da2023-12-29WarningsExact identifier
application number: M012
Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyde2b2e34-62a5-451f-ab68-531d1c9d4d822023-12-29WarningsExact identifier
application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bd2b016ee-5329-45bf-9d71-d626204169cf2023-12-29WarningsExact identifier
application number: M012
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDeMoulas Market Baskete92d2f64-9690-42d3-b787-cafade3a89992023-12-29WarningsExact identifier
application number: M012
Cold and Sinus Maxium StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basket6e5ca8e1-5a03-4e77-b385-d44387fb3bfc2023-12-29WarningsExact identifier
application number: M012
Cold, Flu and Sore Throat Maxium StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketd98029c0-ccd9-47e1-996f-c7786cd4ecca2023-12-29WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC0f2be061-bd0a-4e62-b994-6d0768ea647a2023-12-29WarningsExact identifier
application number: M012
Tussin CF Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDeMoulas Market Basketc19b9997-4037-48f3-b905-86da421a292d2023-12-29WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.0239ada0-644d-4ef4-a3b8-df70246a3bc22023-12-21WarningsExact identifier
application number: M012
HempNesicMENTHOL, CAMPHORBlaine Labs Inc.a698502d-c1c5-41ca-8142-74338b834c8b2023-12-21WarningsExact identifier
application number: M012
Father Johns Cough Medicine PlusNASAL DECONGESTANTOakhurst Company8b8aab0f-251b-6bd8-e053-2995a90ad7482023-12-18WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBROakhurst Company8b8a249d-55af-cc98-e053-2995a90a431d2023-12-18WarningsExact identifier
application number: M012
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79d92d2-d73c-d44f-e053-2995a90a03d92023-12-15WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
application number: M012
Father Johns MedicineDEXTROMETHORPHAN HBRHumco Holding Group, Inca7b0669f-8da1-5a44-e053-2995a90a84d92023-12-15WarningsExact identifier
application number: M012
Ephedrine HydrochlorideEPHEDRINE HYDROCHLORIDEWalgreen Companybcb81dc1-d854-30c0-e053-2a95a90a9fc72023-12-14WarningsExact identifier
application number: M012
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
application number: M012
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Sinus Severe, Circle KACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store products, Inc.e78c456f-f62e-596d-e053-2995a90a23972023-12-14WarningsExact identifier
application number: M012
Non-Drowsy Max ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATEDLil' Drug Store Products, Inc.e79f1a92-d8ea-e3f9-e053-2a95a90a2d372023-12-14WarningsExact 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 TabletPSNf171a389-8b22-429c-86bc-272156fdc1b73
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf171a389-8b22-429c-86bc-272156fdc1b73
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf171a389-8b22-429c-86bc-272156fdc1b73
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf171a389-8b22-429c-86bc-272156fdc1b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-167-02539430167022 BLISTER PACK in 1 CARTON (53943-167-02) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2013-11-110000-00-00NoNoCurrent