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 68 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81mgASPIRIN 81MGLodaat LLC6a35f38c-a240-4f8c-9a8e-8d283b67b55b2024-06-04WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN 81MGLodaat LLC1ec12f4b-de05-4990-a7b7-f82d867361de2024-06-04WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Company0a28a4f1-d947-489b-be28-36ba10b581cf2024-06-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack77fb237f-28b5-486b-b9ef-cb324d5cc0bd2024-05-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepackb5053cf5-209d-4106-afc2-cf9af85f4a692024-05-29WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf129bc0e-1ef1-42a8-8668-2ee88ffc85e32024-05-23WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Childrens Pain and FeverACETAMINOPHENAmerisource Bergen074fdf65-f6ce-46d4-87cc-46911c01cca52024-05-23WarningsExact identifier
application number: M013
DG Health Childrens Pain and FeverACETAMINOPHENDolgencorp, LLC779cf607-245f-408a-81e8-8000c0ea4c4a2024-05-22WarningsExact identifier
application number: M013
good sense pain and fever infantsACETAMINOPHENL. Perrigo Company7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb42024-05-21WarningsExact identifier
application number: M013
Extra Strength Night Time Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp2b8f83ed-1ca9-49ac-9b2a-2609b68200f92024-05-21WarningsExact identifier
application number: M013
Acetaminophen SolutionACETAMINOPHENPatrin Pharma, Inc.52ae729b-2255-420c-8db8-cabdc2b747962024-05-21WarningsExact identifier
application number: M013
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2f9da3d6-229d-44d1-bd94-4bcddbbdb1202024-05-20WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS07d34e7a-c0c6-f3c4-e063-6294a90aa5c32024-05-18WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutionsbcb7eb24-16cb-439e-879f-48d2f5e8ba832024-05-17WarningsExact identifier
application number: M013
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC26266777-185d-4110-a8a7-56846aab25422024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutions1b4db77f-b254-4db5-8e98-d46850140a9b2024-05-16WarningsExact identifier
application number: M013
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
application number: M013
Kosher Meds Childrens Allergy ReliefDIPHENHYDRAMINE HCLMollec Inc42ad618b-d2e5-4c58-9407-386df4fe40042024-05-15WarningsExact 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