FDA.reportPublic FDA data

Aspica (Aspirin)

Product NDC
49638-101
Requested package NDC
49638-101-12
11-digit product format
496380101
Labeler code
49638
Product ID
49638-101_5e87c71c-c05a-4333-a63d-ff20f85cc3d6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
America Medic & Science, LLC
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-06
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage49638-10149638-101-12IInactivated by FDA2026-10-05

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-101-122024-01-11C16284748780-1f386c64a-3487-0266-e053-dadaa90a7c1a9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd
49638-101-122023-01-30C16284748780-1f386c64a-3487-0266-e053-dadaa90a7c1a9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49638-101-12Aspica (Aspirin)120 in 1 BOTTLETABLET, DELAYED RELEASE1204
49638-101-12Aspica (Aspirin)1 in 1 CARTONTABLET, DELAYED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-101ASPICA (ASPIRIN) (ASPIRIN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]4Legacy NDC, 2 package rows20240117_9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd4
308416aspirin 81 MG Delayed Release Oral TabletSCD9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd4
308416ASA 81 MG Delayed Release Oral TabletSY9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd4
308416aspirin 81 MG Enteric Coated Oral TabletSY9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49638-101-12496380101121 BOTTLE in 1 CARTON (49638-101-12) > 120 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-060000-00-00NoNoCurrent