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 6 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
application number: M012
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
application number: M012
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact 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