FDA.reportPublic FDA data

LOW DOSE ASPIRIN

Product NDC
0615-8414
11-digit product format
006158414
Labeler code
0615
Product ID
0615-8414_d1aae137-9f68-4944-bcf4-c84bad592724
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-19
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOW DOSE ASPIRIN

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
0615-8414-05LOW DOSE ASPIRIN15 in 1 BLISTER PACKTABLET, COATED159
0615-8414-28LOW DOSE ASPIRIN28 in 1 BLISTER PACKTABLET, COATED289
0615-8414-39LOW DOSE ASPIRIN30 in 1 BLISTER PACKTABLET, COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8414LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 3 package rows20250302_ed9a71d6-a56e-416a-bb89-6d41307efc5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNed9a71d6-a56e-416a-bb89-6d41307efc5a9
308416aspirin 81 MG Delayed Release Oral TabletSCDed9a71d6-a56e-416a-bb89-6d41307efc5a9
308416ASA 81 MG Delayed Release Oral TabletSYed9a71d6-a56e-416a-bb89-6d41307efc5a9
308416aspirin 81 MG Enteric Coated Oral TabletSYed9a71d6-a56e-416a-bb89-6d41307efc5a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8414-050061584140515 TABLET, COATED in 1 BLISTER PACK (0615-8414-05) 2023-08-102026-10-31NoNoHistorical
0615-8414-280061584142828 in 1 BLISTER PACKHistorical
0615-8414-390061584143930 TABLET, COATED in 1 BLISTER PACK (0615-8414-39) 2021-11-032026-10-31NoNoCurrent