FDA.reportPublic FDA data

Aspirin Low Dose Chewable Orange

Product NDC
0615-8257
11-digit product format
006158257
Labeler code
0615
Product ID
0615-8257_8056aabb-a04d-4c0a-bd3f-a4865ced33ed
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-27
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 Chewable Orange
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui318272

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0615-8257-05Aspirin Low Dose Chewable Orange15 in 1 BLISTER PACKTABLET, CHEWABLE1510
0615-8257-28Aspirin Low Dose Chewable Orange28 in 1 BLISTER PACKTABLET, CHEWABLE2810
0615-8257-30Aspirin Low Dose Chewable Orange6 in 1 BOX, UNIT-DOSETABLET, CHEWABLE610
0615-8257-30Aspirin Low Dose Chewable Orange5 in 1 BLISTER PACKTABLET, CHEWABLE510
0615-8257-39Aspirin Low Dose Chewable Orange30 in 1 BLISTER PACKTABLET, CHEWABLE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8257ASPIRIN LOW DOSE CHEWABLE ORANGE (ASPIRIN) TABLET, CHEWABLE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]10Current NDC, Legacy NDC, 5 package rows20250126_dbdc7cae-b2ed-4504-83a0-0a41b4e45003.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSNdbdc7cae-b2ed-4504-83a0-0a41b4e4500310
318272aspirin 81 MG Chewable TabletSCDdbdc7cae-b2ed-4504-83a0-0a41b4e4500310
318272ASA 81 MG Chewable TabletSYdbdc7cae-b2ed-4504-83a0-0a41b4e4500310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8257-050061582570515 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8257-05) 2020-02-210000-00-00NoNoCurrent
0615-8257-280061582572828 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8257-28) 2025-01-16NoNoHistorical
0615-8257-30006158257306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8257-30) / 5 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2022-05-310000-00-00NoNoCurrent
0615-8257-390061582573930 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8257-39) 2018-11-120000-00-00NoNoCurrent