FDA.reportPublic FDA data

Sinus Severe

Product NDC
50844-572
11-digit product format
508440572
Labeler code
50844
Product ID
50844-572_dc7e7b50-49a8-4d8b-98df-2f5edfb9d40d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-15
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
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
Sinus Severe
Listing expiration
2027-12-31

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
d5c8b248-6d82-4eac-881c-0b9d0a0de8f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-572-02Sinus Severe1 in 1 CARTONTABLET, FILM COATED18
50844-572-02Sinus Severe12 in 1 BLISTER PACKTABLET, FILM COATED128
50844-572-08Sinus Severe2 in 1 CARTONTABLET, FILM COATED28
50844-572-08Sinus Severe12 in 1 BLISTER PACKTABLET, FILM COATED128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-572SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 4 package rows20250221_d5c8b248-6d82-4eac-881c-0b9d0a0de8f1.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 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
application number: M012
TusnelDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division805dc611-355a-4af5-bf19-464c3290c5c62025-12-31WarningsExact identifier
application number: M012
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONcc774d33-96ce-4992-ad30-3cb03b0d119d2025-12-31WarningsExact identifier
application number: M012
Tusnel SFDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cb43b4df-5ccc-416e-abcd-98f079b3f2bb2025-12-31WarningsExact identifier
application number: M012
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.63541753-de8d-42fe-a9b3-a5eac3fcdca42025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
application number: M012
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
application number: M012
Tusnel-DM PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION64e36b02-b5be-4d20-8818-cb5b235966712025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f89a64-f4a4-f909-e053-2a91aa0ad44d2025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f65f59-7ea1-adce-e053-2991aa0a6f1f2025-12-31WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLBestco Inc.77f9e176-d87a-beed-e053-2991aa0aac202025-12-31WarningsExact identifier
application number: M012
Sugar Free Cherry Cough DropsMENTHOLBestco Inc.7858f380-bef7-3d30-e053-2a91aa0a7ea62025-12-31WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLBestCo Inc.26a22cfd-395b-4ffb-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M012
Limpia PechoDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf32025-12-31WarningsExact identifier
application number: M012
Cherry Sore Throat LozengesBENZOCAINEBestco Inc.737efd41-2d59-6013-e053-2a91aa0a6c632025-12-31WarningsExact identifier
application number: M012
Best Health Menthol Cough DropsMENTHOLBestco LLCdda66a3c-9006-ff1a-e053-2a95a90abfb32025-12-31WarningsExact identifier
application number: M012
Rynex DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEdwards Pharmaceuticals, Inc7be2c282-24ba-4f19-9b14-872d3f5746a72025-12-31WarningsExact 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 TabletPSNd5c8b248-6d82-4eac-881c-0b9d0a0de8f18
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDd5c8b248-6d82-4eac-881c-0b9d0a0de8f18
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYd5c8b248-6d82-4eac-881c-0b9d0a0de8f18
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYd5c8b248-6d82-4eac-881c-0b9d0a0de8f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-572-02508440572021 BLISTER PACK in 1 CARTON (50844-572-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-03-150000-00-00NoNoCurrent
50844-572-08508440572082 BLISTER PACK in 1 CARTON (50844-572-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-03-15NoNoCurrent