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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

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

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