Direct Safety Extra Strength Aspirin Free

Product NDC
61245-175
11-digit product format
612450175
Labeler code
61245
Product ID
61245-175_3e5d7595-9e65-3fd6-e063-6394a90a6f80
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Conney Safety Products, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-31
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
Direct Safety Extra Strength Aspirin Free
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
a524c36a-38f3-4266-8f45-589e19400328Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61245-175-13Direct Safety Extra Strength Aspirin Free250 in 1 BOXTABLET, FILM COATED25011
61245-175-13Direct Safety Extra Strength Aspirin Free2 in 1 PACKETTABLET, FILM COATED211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61245-175DIRECT SAFETY EXTRA STRENGTH ASPIRIN FREE (ACETAMINOPHEN) TABLET, FILM COATED [CONNEY SAFETY PRODUCTS, LLC]10Current NDC, Legacy NDC, 2 package rows20241030_a524c36a-38f3-4266-8f45-589e19400328.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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
application number: M013
Children AcetaminophenACETAMINOPHENAARNA USA INC.25bcb9d5-f388-4ae7-8037-970ffe8d17f02025-05-16WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst35478de8-50d0-5d0a-e063-6294a90a88ba2025-05-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
application number: M013
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa524c36a-38f3-4266-8f45-589e1940032811
198440acetaminophen 500 MG Oral TabletSCDa524c36a-38f3-4266-8f45-589e1940032811
198440APAP 500 MG Oral TabletSYa524c36a-38f3-4266-8f45-589e1940032811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61245-175-1361245017513250 PACKET in 1 BOX (61245-175-13) / 2 TABLET, FILM COATED in 1 PACKET250 packet2013-05-310000-00-00NoNoCurrent