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 43 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC HealthCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3f6dd-751d-1dfe-e063-6394a90a0dbb2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEMedical Group Care LLCf4a90af2-47af-ac8c-e053-2a95a90ab97e2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEMedical Group Care LLC043b3639-ab38-adff-e063-6394a90a2ade2026-03-25WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATEWinCo Foods, LLC4535fa03-64ac-4ec6-9d0c-b372bb12773b2026-03-25WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3e73a5f7-5976-4839-9705-c1730ff6bf302026-03-25WarningsExact identifier
application number: M012
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
application number: M012
Cold and Flu Relief Multi symptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC9beeeb3b-6b26-4b9a-843b-ce3658d1debe2026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefNIGHTTIME COLD AND FLU RELIEFGrocery Outleta58459e3-6ada-4d99-9e22-1a01076761512026-03-25WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGGrocery Outlet2f90dfb6-4257-44a8-a685-1873645d1c962026-03-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4d887ed0-4532-5125-e063-6394a90ac44d2026-03-24WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS HEALTH CORP2ba90b91-2e35-4701-e063-6294a90a75542026-03-24WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGTWIN MED LLCe31bd69f-97ab-9d99-e053-2995a90a580e2026-03-24WarningsExact identifier
application number: M012
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
application number: M012
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCed28bfa9-3768-4f42-ae5e-1c527b4456d12026-03-24WarningsExact identifier
application number: M012
Gencare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEPIONEER LIFE SCIENCES, LLC7a02cbb6-c083-4d91-977b-9d53cb3e27842026-03-24WarningsExact identifier
application number: M012
Sinus Severe DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCb65baa7c-8197-4361-b3ef-e60eba38dca12026-03-24WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreense9a53a2c-c5e8-48ba-97d9-c1e3cbd8da4b2026-03-24WarningsExact identifier
application number: M012
Mucus Relief Congestion and Headache Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2638b541-e680-4949-a7c7-fcee165cbc922026-03-23WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)778dc0fb-30c3-4fbf-856a-7bca28181b392026-03-23WarningsExact 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