FDA.reportPublic FDA data

aspirin

Product NDC
0574-7034
11-digit product format
005747034
Labeler code
0574
Product ID
0574-7034_a6ca751c-7438-4a0f-adae-d176f73f4915
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1990-09-01
Substance
ASPIRIN
Active strength
300 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN300 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
198464Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cce244aa-cd79-49c8-b68e-267f2bd0ef67Available 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
0574-7034-12aspirin12 in 1 CARTONSUPPOSITORY126
0574-7034-12aspirin1 in 1 PACKETSUPPOSITORY16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7034-12EA - Each0574-7034be2a527b-764c-4da5-9f7f-363b796a36fe12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPASPIRIN SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7034ASPIRIN SUPPOSITORY [PADAGIS US LLC]6Current NDC, Legacy NDC, 2 package rows20241023_cce244aa-cd79-49c8-b68e-267f2bd0ef67.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
aspirinASPIRINPadagis US LLCcce244aa-cd79-49c8-b68e-267f2bd0ef672022-04-30WarningsExact identifier
ndc (product): 0574-7034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198464aspirin 300 MG Rectal SuppositoryPSNcce244aa-cd79-49c8-b68e-267f2bd0ef676
198464aspirin 300 MG Rectal SuppositorySCDcce244aa-cd79-49c8-b68e-267f2bd0ef676
198464ASA 300 MG Rectal SuppositorySYcce244aa-cd79-49c8-b68e-267f2bd0ef676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7034-120057470341212 PACKET in 1 CARTON (0574-7034-12) / 1 SUPPOSITORY in 1 PACKET12 packet1990-09-010000-00-00NoNoCurrent