FDA.reportPublic FDA data

PhysiciansCare Sinus

Product NDC
0924-0133
11-digit product format
009240133
Labeler code
0924
Product ID
0924-0133_3e4c77d4-32d6-21c7-e063-6294a90a9a30
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Acme United Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-29
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
PhysiciansCare Sinus
Brand name suffix
Non-Drowsy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049182Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6daf3ef-f386-4de4-b38e-d0b90c9ae62bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0133-00PhysiciansCare SinusNon-Drowsy1 in 1 PACKETTABLET, FILM COATED112
0924-0133-01PhysiciansCare SinusNon-Drowsy50 in 1 CARTONTABLET, FILM COATED5012
0924-0133-03PhysiciansCare SinusNon-Drowsy10 in 1 CARTONTABLET, FILM COATED1012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0133PHYSICIANSCARE SINUS NON-DROWSY (PHENYLEPHRINE HCL) TABLET, FILM COATED [ACME UNITED CORPORATION]11Current NDC, Legacy NDC, 3 package rows20250210_a6daf3ef-f386-4de4-b38e-d0b90c9ae62b.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNa6daf3ef-f386-4de4-b38e-d0b90c9ae62b12
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDa6daf3ef-f386-4de4-b38e-d0b90c9ae62b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-0133-00009240133001 in 1 PACKETHistorical
0924-0133-010092401330150 PACKET in 1 CARTON (0924-0133-01) / 1 TABLET, FILM COATED in 1 PACKET (0924-0133-00) 50 packet2012-01-290000-00-00NoNoCurrent
0924-0133-030092401330310 PACKET in 1 CARTON (0924-0133-03) / 1 TABLET, FILM COATED in 1 PACKET (0924-0133-00) 10 packet2012-01-290000-00-00NoNoCurrent