Aspirin

Product NDC
68788-8598
Requested package NDC
68788-8598-8
11-digit product format
687888598
Labeler code
68788
Product ID
68788-8598_a377aab1-ed08-402b-bab2-ca2ea56e7ce1
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
343
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
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
2027-12-31
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
Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e3633ff-64a4-4a72-addc-a3babea040b5Available on FDA.report

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
68788-8598-8Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE13
68788-8598-8Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8598-8EA - Each68788-859895566945-4319-45fd-8c9e-4d7a2957fa6f12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8598ASPIRIN TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250206_5e3633ff-64a4-4a72-addc-a3babea040b5.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINPreferred Pharmaceuticals Inc.5e3633ff-64a4-4a72-addc-a3babea040b52026-03-09WarningsExact identifier
ndc (package): 68788-8598-8
ndc (product): 68788-8598
ndc11 (package): 68788859808

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN5e3633ff-64a4-4a72-addc-a3babea040b53
308416aspirin 81 MG Delayed Release Oral TabletSCD5e3633ff-64a4-4a72-addc-a3babea040b53
308416ASA 81 MG Delayed Release Oral TabletSY5e3633ff-64a4-4a72-addc-a3babea040b53
308416aspirin 81 MG Enteric Coated Oral TabletSY5e3633ff-64a4-4a72-addc-a3babea040b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8598-8687888598081 BOTTLE, PLASTIC in 1 CARTON (68788-8598-8) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2024-03-07NoNoCurrent