FDA.reportPublic FDA data

ASPIRIN

Product NDC
49483-011
11-digit product format
494830011
Labeler code
49483
Product ID
49483-011_0acac93d-0f05-0658-e063-6294a90a83c3
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TIME CAP LABS INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-02
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 Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui212033

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
49483-011-002021-11-22C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets
49483-011-012021-11-22C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets
49483-011-102021-11-22C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets
49483-011-002020-01-31C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets
49483-011-012020-01-31C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets
49483-011-102020-01-31C16284748780-19d75b9d0-7b64-f424-e053-dadaa90a57ceAspirin 325 mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-011-00ASPIRIN100000 in 1 CARTONTABLET, COATED1000004
49483-011-01ASPIRIN100 in 1 BOTTLE, PLASTICTABLET, COATED1004
49483-011-10ASPIRIN1000 in 1 BOTTLE, PLASTICTABLET, COATED10004
49483-011-31ASPIRIN300 in 1 BOTTLETABLET, COATED3004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-011-01EA - Each49483-0111a8b4a59-e054-44a3-8315-d49574cf89e312012-07-24
49483-011-10EA - Each49483-011d996d20c-42cd-41a2-a29a-679d7f395c7612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET [APOTHECA, INC]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, COATED [TIME CAP LABS INC]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET [APOTHECA, INC]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, COATED [TIME CAP LABS INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET [APOTHECA, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET, COATED [TIME CAP LABS INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET [APOTHECA, INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, COATED [TIME CAP LABS INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET [APOTHECA, INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, COATED [TIME CAP LABS INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET [APOTHECA, INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET, COATED [TIME CAP LABS INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET [APOTHECA, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET, COATED [TIME CAP LABS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET [APOTHECA, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET, COATED [TIME CAP LABS INC]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-011ASPIRIN TABLET, COATED [TIME CAP LABS INC]4Current NDC, Legacy NDC, 4 package rows20231123_fe12519c-3e5f-4592-bd34-2d6b81b981f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSNfe12519c-3e5f-4592-bd34-2d6b81b981f44
212033aspirin 325 MG Oral TabletSCDfe12519c-3e5f-4592-bd34-2d6b81b981f44
212033ASA 325 MG Oral TabletSYfe12519c-3e5f-4592-bd34-2d6b81b981f44
212033aspirin 325 MG Oral TabletPSN01cdc525-f51f-4779-9e3b-01a35dd3bcac2
212033aspirin 325 MG Oral TabletSCD01cdc525-f51f-4779-9e3b-01a35dd3bcac2
212033ASA 325 MG Oral TabletSY01cdc525-f51f-4779-9e3b-01a35dd3bcac2
198467aspirin 325 MG Delayed Release Oral TabletPSN2d368df5-c176-435d-b8b9-a171f972fd141
198467aspirin 325 MG Delayed Release Oral TabletSCD2d368df5-c176-435d-b8b9-a171f972fd141
198467ASA 325 MG Delayed Release Oral TabletSY2d368df5-c176-435d-b8b9-a171f972fd141
198467aspirin 325 MG Enteric Coated Oral TabletSY2d368df5-c176-435d-b8b9-a171f972fd141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-011-0049483001100100000 TABLET, COATED in 1 CARTON (49483-011-00) 2014-04-020000-00-00NoNoCurrent
49483-011-0149483001101100 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-011-01) 2014-04-020000-00-00NoNoCurrent
49483-011-10494830011101000 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-011-10) 2014-04-020000-00-00NoNoCurrent
49483-011-3149483001131300 TABLET, COATED in 1 BOTTLE (49483-011-31) 2023-11-02NoNoCurrent