FDA.reportPublic FDA data

Aspirin

Product NDC
54738-111
11-digit product format
547380111
Labeler code
54738
Product ID
54738-111_5cc3bf1b-4678-6a53-e053-2a91aa0abfa6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-01
Substance
ASPIRIN
Active strength
325 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
ASPIRIN325 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
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
236a5672-556a-4d8f-9bb6-5877e363e747Available 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
54738-111-01Aspirin100 in 1 BOTTLETABLET1002
54738-111-03Aspirin1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-111-01EA - Each54738-1117b3d4297-0e62-466c-afc5-680c41f0bf2412019-01-24
54738-111-03EA - Each54738-111d60bdf92-8a0c-438a-ac19-c0b5ca60059412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-111ASPIRIN TABLET [RICHMOND PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 2 package rows20171030_236a5672-556a-4d8f-9bb6-5877e363e747.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
AspirinASPIRINRichmond Pharmaceuticals, Inc236a5672-556a-4d8f-9bb6-5877e363e7472017-10-30WarningsExact identifier
ndc (product): 54738-111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN236a5672-556a-4d8f-9bb6-5877e363e7472
198467aspirin 325 MG Delayed Release Oral TabletSCD236a5672-556a-4d8f-9bb6-5877e363e7472
198467ASA 325 MG Delayed Release Oral TabletSY236a5672-556a-4d8f-9bb6-5877e363e7472
198467aspirin 325 MG Enteric Coated Oral TabletSY236a5672-556a-4d8f-9bb6-5877e363e7472
198467aspirin 325 MG Delayed Release Oral TabletPSN49f46b08-b2fe-4e4d-b235-983dab9740cc1
198467aspirin 325 MG Delayed Release Oral TabletSCD49f46b08-b2fe-4e4d-b235-983dab9740cc1
198467ASA 325 MG Delayed Release Oral TabletSY49f46b08-b2fe-4e4d-b235-983dab9740cc1
198467aspirin 325 MG Enteric Coated Oral TabletSY49f46b08-b2fe-4e4d-b235-983dab9740cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-111-0154738011101100 TABLET in 1 BOTTLE (54738-111-01) 100 tablet2015-05-010000-00-00NoNoCurrent
54738-111-03547380111031000 TABLET in 1 BOTTLE (54738-111-03) 1000 tablet2015-05-010000-00-00NoNoCurrent