FDA.reportPublic FDA data

Adult Low Dose Pain Reliever

Product NDC
55681-403
11-digit product format
556810403
Labeler code
55681
Product ID
55681-403_4d778657-80f7-179b-e063-6394a90a5481
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
TWIN MED LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Adult Low Dose Pain Reliever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

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
55681-403-03Adult Low Dose Pain Reliever300 in 1 BOTTLETABLET, DELAYED RELEASE3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-403ADULT LOW DOSE PAIN RELIEVER (ASPIRIN) TABLET, DELAYED RELEASE [TWIN MED LLC]1Current NDC, 1 package rows20240815_a395acf4-f487-4c98-8c44-ca2aaaf72deb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNa395acf4-f487-4c98-8c44-ca2aaaf72deb4
308416aspirin 81 MG Delayed Release Oral TabletSCDa395acf4-f487-4c98-8c44-ca2aaaf72deb4
308416ASA 81 MG Delayed Release Oral TabletSYa395acf4-f487-4c98-8c44-ca2aaaf72deb4
308416aspirin 81 MG Enteric Coated Oral TabletSYa395acf4-f487-4c98-8c44-ca2aaaf72deb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55681-403-0355681040303300 TABLET, DELAYED RELEASE in 1 BOTTLE (55681-403-03) 2024-08-01NoNoCurrent