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

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 1 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader610accad-2f8b-4605-9357-a58e6e18d4172026-08-15WarningsExact identifier
application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32026-08-14WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
application number: M012
CHILDRENS DIMETAPP COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY7babf4f6-ca0a-44a7-b1ea-d60e20d36f152026-08-14WarningsExact identifier
application number: M012
CVS Mucus Relief DM and Overnight Cold and FluDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCLCVS75520b77-d40b-4f43-b92a-7a3eba5b493f2026-08-14WarningsExact identifier
application number: M012
CVS Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACYbb24c298-1d00-4378-8de3-b4056220fa752026-08-14WarningsExact identifier
application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact 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