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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GILTUSS DIABETIC DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corpbd367ce1-996b-45bc-865e-b6aafe0ea7b02025-10-09WarningsExact identifier
application number: M012
Giltuss DMDEXTROMETHORPHAN HBRGil Pharmaceutical Corp1a4fe686-3085-4543-bd6c-f20580b1df502025-10-09WarningsExact identifier
application number: M012
Giltuss D Allergy and CongestionCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2ec-df65-e053-2a91aa0a42fb2025-10-09WarningsExact identifier
application number: M012
GilphexGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp.e7c8fb97-02cf-4df6-b477-9ff69d6b675d2025-10-09WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationd9f26677-ddef-4098-b564-9aa5734e088b2025-10-09WarningsExact identifier
application number: M012
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
application number: M012
Equate RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalmart Inc01e1f418-c232-e89e-e063-6294a90abd352025-10-08WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc020942b1-59d4-a19d-e063-6394a90a5d872025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Assorted Flavors 80ctMENTHOLDollar General425d2e63-f5bc-45fb-b330-967ae64cfddb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 200ctMENTHOLDollar General Corporationa17aece2-abd8-452a-9da8-2e303845900b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporationb96268da-d6f2-41e4-ba04-ce419376f6262025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Cherry 30ctMENTHOLDollar General Corporation51ccf39a-ae9b-4e6a-856c-002c296f5d072025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporation8f8a9474-f388-4ede-85f2-86222b15ee582025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 200ctMENTHOLDollar General Corporationf85f1a15-db7f-4bb5-9313-24702660054e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporation61a23ce6-5157-4076-afa7-6a79c62fe9e02025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Honey Lemon 30ctMENTHOLDollar General Corporationd5fb7d9e-b0f6-4424-bf67-9e72b50366b12025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation9f9916f5-83ea-4f36-b8c2-c6fe1f77884b2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporationa23ec89a-de7e-4013-b85b-1593e18dc28e2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 160ctMENTHOLDollar General Corporation1833d3bf-6f01-4122-9f4d-4d8b2423fcbb2025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporationfbe92e39-6470-4634-b976-e316baa2c9952025-10-08WarningsExact 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