FDA.reportPublic FDA data

ASPIRIN LOW DOSE

Product NDC
82568-0003
11-digit product format
825680003
Labeler code
82568
Product ID
82568-0003_347edc8f-6392-b75e-e063-6394a90a1cf5
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN LOW DOSE
Dosage form
TABLET
Route
ORAL
Labeler
AARNA USA INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-10
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ASPIRIN LOW DOSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0003-1ASPIRIN LOW DOSE120 in 1 BOTTLETABLET1201
82568-0003-2ASPIRIN LOW DOSE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0003-1EA - Each82568-000350678e63-75ae-4e80-9308-ecfbd641c96412025-11-13
82568-0003-2EA - Each82568-00038ae16ca3-279e-4078-b72b-bc63fa19396312025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0003ASPIRIN LOW DOSE TABLET [AARNA USA INC.]1Current NDC, 2 package rows20250519_347edc8f-6391-b75e-e063-6394a90a1cf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN347edc8f-6391-b75e-e063-6394a90a1cf51
308416aspirin 81 MG Delayed Release Oral TabletSCD347edc8f-6391-b75e-e063-6394a90a1cf51
308416ASA 81 MG Delayed Release Oral TabletSY347edc8f-6391-b75e-e063-6394a90a1cf51
308416aspirin 81 MG Enteric Coated Oral TabletSY347edc8f-6391-b75e-e063-6394a90a1cf51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0003-182568000301120 TABLET in 1 BOTTLE (82568-0003-1) 120 tablet2025-05-15NoNoHistorical
82568-0003-2825680003021000 TABLET in 1 BOTTLE (82568-0003-2) 1000 tablet2025-05-15NoNoHistorical