FDA.reportPublic FDA data

Sinus Relief

Product NDC
21130-502
11-digit product format
211300502
Labeler code
21130
Product ID
21130-502_c768e454-e3ef-4937-ab71-b89b077c60d3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Better Living Brands, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-23
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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 Relief
Brand name suffix
MAXIMUM STRENGTH
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-502-21Sinus ReliefMAXIMUM STRENGTH2 in 1 CARTONTABLET216
21130-502-21Sinus ReliefMAXIMUM STRENGTH12 in 1 BLISTER PACKTABLET1216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-502SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]15Current NDC, Legacy NDC, 2 package rows20241105_ccd30132-6e29-48a2-a380-7c14984fc723.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 65 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLWal-Mart Stores Incf51d1d52-39c2-4259-8b30-f9ac21edb2652025-12-31WarningsExact identifier
application number: M012
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINRUGBY LABORATORIES51b088bc-b44f-44b9-a08e-133509a35a2c2025-12-30WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRUGBY LABORATORIES60c9e493-f58c-45d6-bade-c952975124032025-12-30WarningsExact identifier
application number: M012
BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAdvanced Generic Corporatione48e46e3-d3fa-4b25-8b07-bbecc4f0b64b2025-12-30WarningsExact identifier
application number: M012
AltitussDEXTROMETHORPHAN HBR, GUAIFENESINAlternative Pharmacal Corporatione4ac96f5-2a3a-42a8-8db5-80de4dcdbd442025-12-30WarningsExact identifier
application number: M012
BiocofDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d62025-12-30WarningsExact identifier
application number: M012
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
application number: M012
AltipresDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAlternative Pharmacal Corporationc5a43107-3eb8-46bb-87bd-20deafe28c3f2025-12-30WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.d02f32c1-716e-4753-abba-ff97c4dc9e222025-12-30WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
application number: M012
NinjacofCHLOPHEDIANOL HCL AND PYRILAMINE MALEATECenturion Labs, LLCe2bca40f-9c27-ec8b-2ff0-ef9847ba20372025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079194-b5e7-d5e6-e063-6394a90a4d8c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307db15-592b-138a-e063-6394a90a23a52025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23087ee3-26a0-e2b8-e063-6394a90abef42025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREECOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.230883da-de48-68e9-e063-6394a90a927c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.23086723-5718-6d02-e063-6394a90a03d22025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNccd30132-6e29-48a2-a380-7c14984fc72316
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDccd30132-6e29-48a2-a380-7c14984fc72316
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYccd30132-6e29-48a2-a380-7c14984fc72316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-502-21211300502212 BLISTER PACK in 1 CARTON (21130-502-21) / 12 TABLET in 1 BLISTER PACK2 blister pack2005-06-230000-00-00NoNoCurrent