FDA.reportPublic FDA data

Aspirin

Product NDC
68016-642
Requested package NDC
68016-642-40
11-digit product format
680160642
Labeler code
68016
Product ID
68016-642_756f7be1-e233-401e-bf99-920cccd18d16
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68016-64268016-642-40DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68016-642-12AspirinLow Dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12016
68016-642-12AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE116
68016-642-40AspirinLow Dose400 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE40016
68016-642-50AspirinLow Dose500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-642-12EA - Each68016-6428b205f4c-a286-41e3-b64c-031ee9c0fbc912022-06-06
68016-642-40EA - Each68016-642d8d52b4f-bcbb-4875-8330-97ed596fb8fe12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [CHAIN DRUG CONSORTIUM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-642ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM]14Legacy NDC, 4 package rows20240517_ff57b70f-6f38-441c-943b-937730ba188c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNff57b70f-6f38-441c-943b-937730ba188c16
308416aspirin 81 MG Delayed Release Oral TabletSCDff57b70f-6f38-441c-943b-937730ba188c16
308416ASA 81 MG Delayed Release Oral TabletSYff57b70f-6f38-441c-943b-937730ba188c16
308416aspirin 81 MG Enteric Coated Oral TabletSYff57b70f-6f38-441c-943b-937730ba188c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-642-4068016064240400 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68016-642-40) 2011-05-010000-00-00NoNoCurrent