FDA.reportPublic FDA data

PhysiciansCare Non Aspirin

Product NDC
0924-0123
11-digit product format
009240123
Labeler code
0924
Product ID
0924-0123_4278957f-fed5-0a17-e063-6294a90a7997
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Acme United Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-20
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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 Non Aspirin
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7006775-bd5b-412f-963d-ce5a158216c5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0123-00PhysiciansCare Non AspirinExtra Strength2 in 1 PACKETTABLET, FILM COATED212
0924-0123-01PhysiciansCare Non AspirinExtra Strength50 in 1 CARTONTABLET, FILM COATED5012
0924-0123-01PhysiciansCare Non AspirinExtra Strength2 in 1 PACKETTABLET, FILM COATED212
0924-0123-02PhysiciansCare Non AspirinExtra Strength2 in 1 PACKETTABLET, FILM COATED212
0924-0123-02PhysiciansCare Non AspirinExtra Strength125 in 1 CARTONTABLET, FILM COATED12512
0924-0123-03PhysiciansCare Non AspirinExtra Strength10 in 1 CARTONTABLET, FILM COATED1012
0924-0123-03PhysiciansCare Non AspirinExtra Strength2 in 1 PACKETTABLET, FILM COATED212
0924-0123-04PhysiciansCare Non AspirinExtra Strength6 in 1 CARTONTABLET, FILM COATED612
0924-0123-05PhysiciansCare Non AspirinExtra Strength20 in 1 CARTONTABLET, FILM COATED2012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0123PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [ACME UNITED CORPORATION]9Current NDC, Legacy NDC, 9 package rows20241205_c7006775-bd5b-412f-963d-ce5a158216c5.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc7006775-bd5b-412f-963d-ce5a158216c512
198440acetaminophen 500 MG Oral TabletSCDc7006775-bd5b-412f-963d-ce5a158216c512
198440APAP 500 MG Oral TabletSYc7006775-bd5b-412f-963d-ce5a158216c512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-0123-00009240123002 TABLET, FILM COATED in 1 PACKET (0924-0123-00) 2012-01-200000-00-00NoNoCurrent
0924-0123-010092401230150 PACKET in 1 CARTON (0924-0123-01) / 2 TABLET, FILM COATED in 1 PACKET50 packet2012-01-200000-00-00NoNoCurrent
0924-0123-0200924012302125 PACKET in 1 CARTON (0924-0123-02) / 2 TABLET, FILM COATED in 1 PACKET125 packet2012-01-200000-00-00NoNoCurrent
0924-0123-030092401230310 PACKET in 1 CARTON (0924-0123-03) / 2 TABLET, FILM COATED in 1 PACKET10 packet2012-01-200000-00-00NoNoCurrent
0924-0123-04009240123046 PACKET in 1 CARTON (0924-0123-04) / 2 TABLET, FILM COATED in 1 PACKET (0924-0123-00) 6 packet2012-01-20NoNoCurrent
0924-0123-050092401230520 PACKET in 1 CARTON (0924-0123-05) / 2 TABLET, FILM COATED in 1 PACKET (0924-0123-00) 20 packet2012-01-20NoNoCurrent