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 19 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC2ee6df99-727a-34c6-e063-6294a90a6bbc2026-07-06WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC28ec213e-fabb-28ec-e063-6394a90ad1022026-07-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRSelect Consumer Group55fc7d6f-cc44-b4c0-e063-6294a90ae4fc2026-07-06WarningsExact identifier
application number: M012
Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLDOLGENCORP, LLCf2eacb1b-8b29-41ec-828a-c1f902ac09342026-07-06WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d10292-e673-9896-e063-6294a90a56742026-07-04WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
application number: M012
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
application number: M012
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
application number: M012
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
application number: M012
NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.161c34b4-3cd2-40b4-b13e-ad980ad4249c2026-07-01WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)437cd589-f5da-4390-b178-609d4537eaab2026-07-01WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL.N.K. International, Inc.9167a80e-fcf0-4b64-97e6-8a8ac566f1342026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART55653790-9400-e63b-e063-6394a90ae5f72026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART55656a74-9721-62cf-e063-6394a90a7eb72026-06-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC5565f02b-ce38-339f-e063-6294a90a671c2026-06-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.b3be2068-39e8-45f8-950e-afaee2c2520f2026-06-29WarningsExact identifier
application number: M012
NIGHTTIME COUGH DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED646f65f4-b9e4-4291-aadc-d2070848d35c2026-06-29WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact 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