FDA.reportPublic FDA data

ASPIRIN

Product NDC
49483-382
11-digit product format
494830382
Labeler code
49483
Product ID
49483-382_7d3ee158-5996-c9c6-e053-2991aa0a844a
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-11
Substance
ASPIRIN
Active strength
500 mg/5001
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
Brand name suffix
EXTRA STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/5001

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198471

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
49483-382-00ASPIRINEXTRA STRENGTH100000 in 1 CARTONTABLET, COATED1000002
49483-382-01ASPIRINEXTRA STRENGTH100 in 1 BOTTLE, PLASTICTABLET, COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-382ASPIRIN EXTRA STRENGTH (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2Current NDC, Legacy NDC, 2 package rows20181218_efc7d42a-241a-422d-bc08-be2f5f774b62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198471aspirin 500 MG Oral TabletPSNefc7d42a-241a-422d-bc08-be2f5f774b622
198471aspirin 500 MG Oral TabletSCDefc7d42a-241a-422d-bc08-be2f5f774b622
198471ASA 500 MG Oral TabletSYefc7d42a-241a-422d-bc08-be2f5f774b622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-382-0049483038200100000 TABLET, COATED in 1 CARTON (49483-382-00) 2018-12-170000-00-00NoNoCurrent
49483-382-0149483038201100 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-382-01) 2018-12-170000-00-00NoNoCurrent